<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03245658</url>
  </required_header>
  <id_info>
    <org_study_id>H-17000277</org_study_id>
    <nct_id>NCT03245658</nct_id>
  </id_info>
  <brief_title>The Effect of Cannabis in Pancreatic Cancer</brief_title>
  <official_title>The Effect of Medical Cannabis Inpatients With Palliative Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jens Rikardt Andersen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Augustinus Fonden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Københavns Universitet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Familien Hede Nielsens Fond</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of malnutrition is overwhelming in pancreatic cancer patients, &gt;80% experience&#xD;
      a weight loss &gt;10% of their habitual weight, which may develop into cancer cachexia. Cachexia&#xD;
      may cause decreased quality of life, increased mortality and morbidity e.g. poorer response&#xD;
      to antitumor treatment, longer length of stay, higher complications rate and shorter life&#xD;
      expectancy. There is currently no effective treatment of cancer cachexia, but clinical&#xD;
      research in medical cannabis show promising results. The cannabinoids THC and CBD show the&#xD;
      highest pharmacological effect, but cannabis consists of &gt;70 cannabinoids. THC and CBD exert&#xD;
      their effect on the endocannabinoid system which modulate physiological systems such as pain,&#xD;
      inflammation, appetite and energy balance. Thus, this potential orexigenic effect from THC&#xD;
      and CBD may improve the nutritional state in patients with pancreatic cancer. Taking the&#xD;
      above scientific rationale and the lack of evidence into account, the relevance of this&#xD;
      clinical trial appears high.&#xD;
&#xD;
      This clinical trial is an eight-week crossover design examining the effects of the&#xD;
      cannabinoids THC and CBD on energy- and protein intake and lean body mass as a measure of&#xD;
      appetite, nausea and quality of life. A characterization of the metabolism is analysed&#xD;
      through a metabolomics analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to investigate the effect of the cannabinoids THC (tetrahydrocannabinol) and CBD&#xD;
      (cannabidiol) on energy- and protein intake and lean body mass in patients with pancreatic&#xD;
      cancer. A metabolomics analysis is conducted to determine the simultaneous and quantitative&#xD;
      intracellular metabolites when medical cannabis is administered in patients with pancreatic&#xD;
      cancer.&#xD;
&#xD;
      The clinical trial is designed as a crossover intervention trial with a four week&#xD;
      intervention period and a four week control period. The study subjects are instructed to&#xD;
      administer individual titered doses of medical cannabis during the intervention period.&#xD;
      Dietary history, height, weight, bio- impedance, VAS scales and quality of life measurements&#xD;
      are conducted at baseline, every second week and at the end of the clinical trial. Six study&#xD;
      subjects are invited to a semi-structured interview. Blood samples and urine samples are used&#xD;
      for the metabolomics analysis thus a research biobank is established.&#xD;
&#xD;
      Study population: 32 study subjects diagnosed with pancreatic cancer in palliative care are&#xD;
      included. Inclusions criteria: adult, weight loss &gt; 5% of habitual weight. Able to understand&#xD;
      and read Danish. Exclusion criteria: regular use of cannabis, psychiatric disorders e.g.&#xD;
      Anorexia Nervosa, alcohol abuse, life expectancy&#xD;
&#xD;
      Descriptive statistics is used to characterize the study population. The statistical analysis&#xD;
      is carried out in R-Project and all primary data are analyzed as intention-to-treat. P value&#xD;
      90% of patients with pancreatic cancer in the palliative phase experience reduced energy- and&#xD;
      protein intake. The quantity of the reduction is, however, very poorly described and appear&#xD;
      to depend on cancer progression.&#xD;
&#xD;
      The trial which is approved by the Research Ethics Committee is expected to commence May 2017&#xD;
      after approval by the Danish Medicines Agency and the Data Protection Agency. The clinical&#xD;
      trial finish no later than February the 6th 2018. The specified time limit is due to the&#xD;
      trial is also basis for a master's thesis in Clinical Nutrition at the Department of&#xD;
      Nutrition, Exercise and Sports, University of Copenhagen. A PhD based on this master thesis&#xD;
      will proceed afterwards. Taking into account the patients' usual control times and to&#xD;
      minimize dropout, patient inclusion takes place ongoing, so that there is a control- and&#xD;
      intervention period at the same time. Outcome measurements including anthropometry and&#xD;
      dietary interviews are carried out at baseline, every two weeks and at the termination of&#xD;
      each period. Quality of life measurements and VAS scales are filled out weekly in both&#xD;
      periods. The semi-structured interview is carried out at the end of the clinical trial.&#xD;
&#xD;
      The results are going to be published, this applies to both positive, inconclusive and&#xD;
      negative results. The clinical trial is registered in the two trial databases&#xD;
      ClinicalTrials.gov and EudraCT (clinicaltrialsregister.eu). Scientific articles based on the&#xD;
      findings are submitted to relevant journals such as The American Journal of Clinical&#xD;
      Nutrition (2014 Impact Factor: 6.770). The results are furthermore used in a master's thesis&#xD;
      in Clinical Nutrition at the Department of Nutrition, Exercise and Sports, University of&#xD;
      Copenhagen by Ninette Renee Jensen and Rikke Lundsgaard Nielsen. The results will be&#xD;
      presented at congresses. reported in scientific articles, in the master&quot;s thesis, in the&#xD;
      information material, on the department's website, at the public master ́s thesis defense as&#xD;
      well as at future congresses, or wherever desired. When the clinical trial is completed a&#xD;
      report is sent to relevant authorities including the Research Ethics Committee and the Danish&#xD;
      Medicines Agency within 90 days of completion.&#xD;
&#xD;
      Necessary permits from the Data Protection Agency, the Danish Medicines Agency and the&#xD;
      Research Ethics Committee are obtained before the initiation of the clinical trial. The&#xD;
      protocol is approved by the Research Ethics Committee. Side effects caused by medical&#xD;
      cannabis varies in the literature, thus an individual titration period is implemented. No&#xD;
      fatal cases have been reported with the use of medical cannabis in human clinical trials.&#xD;
      Potential beneficial effects are expected when the study subjects are being treated with&#xD;
      medical cannabis, since a gain in appetite and quality of life is expected through a&#xD;
      modulation in the endocannabinoid system. Patients are informed that the drug is discontinued&#xD;
      after the intervention period. The two master's thesis students review patient charts weekly&#xD;
      to evaluate potential side effects to the drug. The clinical trial is terminated immediately&#xD;
      in case of serious side effects. Relevant information material is handed out to the study&#xD;
      subjects.&#xD;
&#xD;
      Upon loss of muscle mass and function as seen in cancer cachexia, the administration of&#xD;
      individually titrated doses of medical cannabis could hypothetically slow down the condition&#xD;
      further, by affecting any negative protein - and energy balance through the endocannabinoid&#xD;
      system. When relieving cancer cachexia and improving steady-state, we expect improved&#xD;
      prognosis's for the included patients&#xD;
&#xD;
      The overall objective of the study is that it must be orientated towards clinical&#xD;
      significance, so that it can be implemented in clinical practice, thus benefit patients with&#xD;
      cancer. The short-term goal is that the patients in this trial experience positive effects in&#xD;
      terms of increased appetite and quality of life. Positive effects may contribute to increased&#xD;
      research into this area thus resulting in improved evidence. In the longer term, the aim is&#xD;
      that the results from this study may contribute to a treatment protocol on malnutrition&#xD;
      recommending the use of medical cannabis based on high scientific evidence, so a larger group&#xD;
      of patients with cancer may benefit. The results from the study may be used for&#xD;
      recommendations on doses, side effects and likely beneficial effects when administer medical&#xD;
      cannabis. The metabolomics analysis can contribute to a improved understanding of the cancer&#xD;
      cachexia pathophysiology and management in a more experimental matter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 6, 2017</start_date>
  <completion_date type="Anticipated">October 6, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 6, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy and protein intake</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>Dietary history (% of estimated needs - NRS 2002)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>Bioimpedance (% of body weight, kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite 1</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>VAS (cm on 10 cm scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite 2</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>Dietary history (VAS (cm on 10 cm scale))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite 3</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>EORTC QLQ-C30 (score, standard for the Quality of Life entity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite 4</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life 1</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>EORTC QLQ-C30 (score, standard for the Quality of Life entity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life 2</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life 3</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>VAS (VAS (cm on 10 cm scale))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain 1</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>EORTC QLQ-C30 (score, standard for the Quality of Life entity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain 2</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain 3</measure>
    <time_frame>The outcome measure will be assessed at day 0 and at week 4</time_frame>
    <description>VAS (VAS (cm on 10 cm scale))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (8 weeks)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Patient records, national register</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Neoplasms Pancreatic</condition>
  <condition>Cachexia; Cancer</condition>
  <condition>Cannabis</condition>
  <condition>Appetite Loss</condition>
  <condition>Palliative Medicine</condition>
  <condition>Morbidity</condition>
  <condition>Mortality</condition>
  <arm_group>
    <arm_group_label>THC and CBD Mixture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>32 patients with palliative pancreatic cancer, intervention with oral drops of THC, 25mg/ml and CBD 50mg/ml, daily administered for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>32 patients with palliative pancreatic cancer, no experimental treatment,</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>THC and CBD Mixture</intervention_name>
    <description>Individually titrated doses on daily basis</description>
    <arm_group_label>THC and CBD Mixture</arm_group_label>
    <other_name>Medical cannabis oral drops</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, palliative pancreatic cancer diagnosis, weight loss &gt; 5%, understand and read&#xD;
             Danish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular use of cannabis, psychiatric disorders, alcohol abuse, life expectancy &lt; 6&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Rikardt Andersen, MD, MPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jens Rikardt Andersen, MD, MPA</last_name>
    <phone>004523346654</phone>
    <email>jra@nexs.ku.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rikke Lundsgaard Nielsen, Msc stud</last_name>
    <phone>004540461306</phone>
    <email>gdz384@alumni.ku.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of clinical oncology, Næstved-Roskilde Hospital</name>
      <address>
        <city>Naestved</city>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <contact>
      <last_name>Jens Rikardt Andersen, MD, MPA</last_name>
      <phone>004523346654</phone>
      <email>jra@nexs.ku.dk</email>
    </contact>
    <contact_backup>
      <last_name>Rikke Lundsgaard Nielsen, Msc stud</last_name>
      <phone>004540461306</phone>
      <email>gdz384@alumni.ku.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Jens Rikardt Andersen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <results_reference>
    <citation>Perras C. Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. 2005 Sep;(72):1-4.</citation>
    <PMID>16317825</PMID>
  </results_reference>
  <results_reference>
    <citation>Gartner S, Kruger J, Aghdassi AA, Steveling A, Simon P, Lerch MM, Mayerle J. Nutrition in Pancreatic Cancer: A Review. Gastrointest Tumors. 2016 May;2(4):195-202. doi: 10.1159/000442873. Epub 2016 Jan 8.</citation>
    <PMID>27403414</PMID>
  </results_reference>
  <results_reference>
    <citation>Ware MA, Daeninck P, Maida V. A review of nabilone in the treatment of chemotherapy-induced nausea and vomiting. Ther Clin Risk Manag. 2008 Feb;4(1):99-107. doi: 10.2147/tcrm.s1132.</citation>
    <PMID>18728826</PMID>
  </results_reference>
  <results_reference>
    <citation>Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.</citation>
    <PMID>12648025</PMID>
  </results_reference>
  <results_reference>
    <citation>Slatkin NE. Cannabinoids in the treatment of chemotherapy-induced nausea and vomiting: beyond prevention of acute emesis. J Support Oncol. 2007 May;5(5 Suppl 3):1-9.</citation>
    <PMID>17566383</PMID>
  </results_reference>
  <results_reference>
    <citation>Johnson JR, Lossignol D, Burnell-Nugent M, Fallon MT. An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. J Pain Symptom Manage. 2013 Aug;46(2):207-18. doi: 10.1016/j.jpainsymman.2012.07.014. Epub 2012 Nov 8.</citation>
    <PMID>23141881</PMID>
  </results_reference>
  <results_reference>
    <citation>Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.</citation>
    <PMID>19896326</PMID>
  </results_reference>
  <results_reference>
    <citation>Reuter SE, Martin JH. Pharmacokinetics of Cannabis in Cancer Cachexia-Anorexia Syndrome. Clin Pharmacokinet. 2016 Jul;55(7):807-812. doi: 10.1007/s40262-015-0363-2.</citation>
    <PMID>26883879</PMID>
  </results_reference>
  <results_reference>
    <citation>Gamage TF, Lichtman AH. The endocannabinoid system: role in energy regulation. Pediatr Blood Cancer. 2012 Jan;58(1):144-8. doi: 10.1002/pbc.23367.</citation>
    <PMID>22076835</PMID>
  </results_reference>
  <results_reference>
    <citation>Fox KM, Brooks JM, Gandra SR, Markus R, Chiou CF. Estimation of Cachexia among Cancer Patients Based on Four Definitions. J Oncol. 2009;2009:693458. doi: 10.1155/2009/693458. Epub 2009 Jul 1.</citation>
    <PMID>19587829</PMID>
  </results_reference>
  <results_reference>
    <citation>Gullett N, Rossi P, Kucuk O, Johnstone PA. Cancer-induced cachexia: a guide for the oncologist. J Soc Integr Oncol. 2009 Fall;7(4):155-69.</citation>
    <PMID>19883531</PMID>
  </results_reference>
  <results_reference>
    <citation>Blum D, Omlin A, Fearon K, Baracos V, Radbruch L, Kaasa S, Strasser F; European Palliative Care Research Collaborative. Evolving classification systems for cancer cachexia: ready for clinical practice? Support Care Cancer. 2010 Mar;18(3):273-9. doi: 10.1007/s00520-009-0800-6.</citation>
    <PMID>20076976</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>March 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jens Rikardt Andersen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cachexia</mesh_term>
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nabiximols</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03245658
org study id: H-17000277
nct id: NCT03245658
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence of malnutrition is overwhelming in pancreatic cancer patients, >80% experience
      a weight loss >10% of their habitual weight, which may develop into cancer cachexia. Cachexia
      may cause decreased quality of life, increased mortality and morbidity e.g. poorer response
      to antitumor treatment, longer length of stay, higher complications rate and shorter life
      expectancy. There is currently no effective treatment of cancer cachexia, but clinical
      research in medical cannabis show promising results. The cannabinoids THC and CBD show the
      highest pharmacological effect, but cannabis consists of >70 cannabinoids. THC and CBD exert
      their effect on the endocannabinoid system which modulate physiological systems such as pain,
      inflammation, appetite and energy balance. Thus, this potential orexigenic effect from THC
      and CBD may improve the nutritional state in patients with pancreatic cancer. Taking the
      above scientific rationale and the lack of evidence into account, the relevance of this
      clinical trial appears high.

      This clinical trial is an eight-week crossover design examining the effects of the
      cannabinoids THC and CBD on energy- and protein intake and lean body mass as a measure of
      appetite, nausea and quality of life. A characterization of the metabolism is analysed
      through a metabolomics analysis.
The aim is to investigate the effect of the cannabinoids THC (tetrahydrocannabinol) and CBD
      (cannabidiol) on energy- and protein intake and lean body mass in patients with pancreatic
      cancer. A metabolomics analysis is conducted to determine the simultaneous and quantitative
      intracellular metabolites when medical cannabis is administered in patients with pancreatic
      cancer.

      The clinical trial is designed as a crossover intervention trial with a four week
      intervention period and a four week control period. The study subjects are instructed to
      administer individual titered doses of medical cannabis during the intervention period.
      Dietary history, height, weight, bio- impedance, VAS scales and quality of life measurements
      are conducted at baseline, every second week and at the end of the clinical trial. Six study
      subjects are invited to a semi-structured interview. Blood samples and urine samples are used
      for the metabolomics analysis thus a research biobank is established.

      Study population: 32 study subjects diagnosed with pancreatic cancer in palliative care are
      included. Inclusions criteria: adult, weight loss > 5% of habitual weight. Able to understand
      and read Danish. Exclusion criteria: regular use of cannabis, psychiatric disorders e.g.
      Anorexia Nervosa, alcohol abuse, life expectancy

      Descriptive statistics is used to characterize the study population. The statistical analysis
      is carried out in R-Project and all primary data are analyzed as intention-to-treat. P value
      90% of patients with pancreatic cancer in the palliative phase experience reduced energy- and
      protein intake. The quantity of the reduction is, however, very poorly described and appear
      to depend on cancer progression.

      The trial which is approved by the Research Ethics Committee is expected to commence May 2017
      after approval by the Danish Medicines Agency and the Data Protection Agency. The clinical
      trial finish no later than February the 6th 2018. The specified time limit is due to the
      trial is also basis for a master's thesis in Clinical Nutrition at the Department of
      Nutrition, Exercise and Sports, University of Copenhagen. A PhD based on this master thesis
      will proceed afterwards. Taking into account the patients' usual control times and to
      minimize dropout, patient inclusion takes place ongoing, so that there is a control- and
      intervention period at the same time. Outcome measurements including anthropometry and
      dietary interviews are carried out at baseline, every two weeks and at the termination of
      each period. Quality of life measurements and VAS scales are filled out weekly in both
      periods. The semi-structured interview is carried out at the end of the clinical trial.

      The results are going to be published, this applies to both positive, inconclusive and
      negative results. The clinical trial is registered in the two trial databases
      ClinicalTrials.gov and EudraCT (clinicaltrialsregister.eu). Scientific articles based on the
      findings are submitted to relevant journals such as The American Journal of Clinical
      Nutrition (2014 Impact Factor: 6.770). The results are furthermore used in a master's thesis
      in Clinical Nutrition at the Department of Nutrition, Exercise and Sports, University of
      Copenhagen by Ninette Renee Jensen and Rikke Lundsgaard Nielsen. The results will be
      presented at congresses. reported in scientific articles, in the master"s thesis, in the
      information material, on the department's website, at the public master ́s thesis defense as
      well as at future congresses, or wherever desired. When the clinical trial is completed a
      report is sent to relevant authorities including the Research Ethics Committee and the Danish
      Medicines Agency within 90 days of completion.

      Necessary permits from the Data Protection Agency, the Danish Medicines Agency and the
      Research Ethics Committee are obtained before the initiation of the clinical trial. The
      protocol is approved by the Research Ethics Committee. Side effects caused by medical
      cannabis varies in the literature, thus an individual titration period is implemented. No
      fatal cases have been reported with the use of medical cannabis in human clinical trials.
      Potential beneficial effects are expected when the study subjects are being treated with
      medical cannabis, since a gain in appetite and quality of life is expected through a
      modulation in the endocannabinoid system. Patients are informed that the drug is discontinued
      after the intervention period. The two master's thesis students review patient charts weekly
      to evaluate potential side effects to the drug. The clinical trial is terminated immediately
      in case of serious side effects. Relevant information material is handed out to the study
      subjects.

      Upon loss of muscle mass and function as seen in cancer cachexia, the administration of
      individually titrated doses of medical cannabis could hypothetically slow down the condition
      further, by affecting any negative protein - and energy balance through the endocannabinoid
      system. When relieving cancer cachexia and improving steady-state, we expect improved
      prognosis's for the included patients

      The overall objective of the study is that it must be orientated towards clinical
      significance, so that it can be implemented in clinical practice, thus benefit patients with
      cancer. The short-term goal is that the patients in this trial experience positive effects in
      terms of increased appetite and quality of life. Positive effects may contribute to increased
      research into this area thus resulting in improved evidence. In the longer term, the aim is
      that the results from this study may contribute to a treatment protocol on malnutrition
      recommending the use of medical cannabis based on high scientific evidence, so a larger group
      of patients with cancer may benefit. The results from the study may be used for
      recommendations on doses, side effects and likely beneficial effects when administer medical
      cannabis. The metabolomics analysis can contribute to a improved understanding of the cancer
      cachexia pathophysiology and management in a more experimental matter.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Energy and protein intake
time frame: The outcome measure will be assessed at day 0 and at week 4
description: Dietary history (% of estimated needs - NRS 2002)
measure: Lean body mass
time frame: The outcome measure will be assessed at day 0 and at week 4
description: Bioimpedance (% of body weight, kg)
measure: Appetite 1
time frame: The outcome measure will be assessed at day 0 and at week 4
description: VAS (cm on 10 cm scale)
measure: Appetite 2
time frame: The outcome measure will be assessed at day 0 and at week 4
description: Dietary history (VAS (cm on 10 cm scale))
measure: Appetite 3
time frame: The outcome measure will be assessed at day 0 and at week 4
description: EORTC QLQ-C30 (score, standard for the Quality of Life entity)
measure: Appetite 4
time frame: The outcome measure will be assessed at day 0 and at week 4
description: EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
measure: Quality of life 1
time frame: The outcome measure will be assessed at day 0 and at week 4
description: EORTC QLQ-C30 (score, standard for the Quality of Life entity)
measure: Quality of life 2
time frame: The outcome measure will be assessed at day 0 and at week 4
description: EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
measure: Quality of life 3
time frame: The outcome measure will be assessed at day 0 and at week 4
description: VAS (VAS (cm on 10 cm scale))
measure: Pain 1
time frame: The outcome measure will be assessed at day 0 and at week 4
description: EORTC QLQ-C30 (score, standard for the Quality of Life entity)
measure: Pain 2
time frame: The outcome measure will be assessed at day 0 and at week 4
description: EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
measure: Pain 3
time frame: The outcome measure will be assessed at day 0 and at week 4
description: VAS (VAS (cm on 10 cm scale))
measure: Mortality (8 weeks)
time frame: 8 weeks
description: Patient records, national register
arm group label: THC and CBD Mixture
arm group type: Experimental
description: 32 patients with palliative pancreatic cancer, intervention with oral drops of THC, 25mg/ml and CBD 50mg/ml, daily administered for 4 weeks
arm group label: Control
arm group type: No Intervention
description: 32 patients with palliative pancreatic cancer, no experimental treatment,
intervention type: Drug
intervention name: THC and CBD Mixture
description: Individually titrated doses on daily basis
arm group label: THC and CBD Mixture
other name: Medical cannabis oral drops
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Rikardt Andersen, MD, MPA
role: Principal Investigator
affiliation: University of Copenhagen
last name: Jens Rikardt Andersen, MD, MPA
phone: 004523346654
email: jra@nexs.ku.dk
last name: Rikke Lundsgaard Nielsen, Msc stud
phone: 004540461306
email: gdz384@alumni.ku.dk
facility: 
contact: 
contact backup: 
investigator: 
country: Denmark
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PMID: 23141881
citation: Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.
PMID: 19896326
citation: Reuter SE, Martin JH. Pharmacokinetics of Cannabis in Cancer Cachexia-Anorexia Syndrome. Clin Pharmacokinet. 2016 Jul;55(7):807-812. doi: 10.1007/s40262-015-0363-2.
PMID: 26883879
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PMID: 22076835
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PMID: 20076976
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jens Rikardt Andersen
investigator title: Associate Professor
mesh term: Cachexia
mesh term: Marijuana Abuse
mesh term: Nabiximols
sharing ipd: No