<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/NCT02980653</url>
  </required_header>
  <id_info>
    <org_study_id>TTYMG1403</org_study_id>
    <nct_id>NCT02980653</nct_id>
  </id_info>
  <brief_title>Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&amp;N Cancer Who Receiving CCRT</brief_title>
  <official_title>A Phase II Study Assessing the Efficacy of Prophylaxis Use of Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With Head and Neck Cancer Who Receiving Concurrent Chemoradiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TTY Biopharm</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>TTY Biopharm</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To evaluate the population prevalence of critical body weight loss ( more than 5% from&#xD;
      baseline) in patients with Head and Neck cancer.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To evaluate the impact of appetite, and performance status; To evaluate the change of quality&#xD;
      of life (QoL); To evaluate the incidence of infection and hospitalization; To evaluate the&#xD;
      safety profiles&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis testing will be used to determine the patient number in this study. According to a&#xD;
      preliminary data at CGMH-LK, the investigators have the untreated patients with population&#xD;
      prevalence of critical weight loss that is 0.56, and the investigators assume the study&#xD;
      treated population prevalence is 0.4, power set in 0.9, alpha set in 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Critical body weight loss</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the population prevalence of critical body weight loss ( &gt; 5% from baseline) in patients with Head and Neck cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of appetite</measure>
    <time_frame>12 weeks</time_frame>
    <description>The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study. The assessment of appetite will be performed by the visual analogue scale(VAS) within the range of 0-100mm(please refer Appendix II). The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of performance status</measure>
    <time_frame>12 weeks</time_frame>
    <description>The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study. The measurement will base on ECOG performance status scale(please refer Appendix I). The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of quality of life (QoL)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Quality of life (QOL) will be evaluated since patient registration to off study by means of the Functional Assessment of Cancer Therapy-Head and Neck (FACT-. H&amp;N), Version 4 (Traditional Chinese) (please refer Appendix III). The questionnaire will be completed under the assistance of a trained study nurse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of infection and hospitalization</measure>
    <time_frame>12 weeks</time_frame>
    <description>If any patient in the study period (3 months) suffer infection or hospitalization, that should be recorded on Case Report Form for the descriptive statistics analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profiles (percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Adverse event / toxicity assessment are based on NCI- Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03), please refer Appendix IV), and will be evaluated before the treatment, and then repeated each visit until off study. The incidence and percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurability of Anthropometric Evaluation</measure>
    <time_frame>12 weeks</time_frame>
    <description>Anthropometric evaluation is including body weight and body mass index.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lab test</measure>
    <time_frame>12 weeks</time_frame>
    <description>Lab test should be conducted every patient's visit for safety assessment. CRP and TNFα will be exanimated at screening and every 4 weeks of the treatment period.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Megestrol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Megestrol acetate (MA) 400 mg/day</intervention_name>
    <description>Megestrol acetate (MA) will be given on 400 mg/day as eligible patient begin CCRT. Total treatment period is for a maximum of 12 weeks calculated from the date of first dose.</description>
    <arm_group_label>Megestrol</arm_group_label>
    <other_name>Megest</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who is confirmed the diagnosis of head and neck cancer and will receive&#xD;
             concurrent chemoradiotherapy (CCRT).&#xD;
&#xD;
          -  Patient who is capable to understand and complete questionnaires&#xD;
&#xD;
          -  Patient who is convenient to receive body weight measurement&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks&#xD;
&#xD;
          -  Age over 20 years old at registration&#xD;
&#xD;
          -  Voluntarily signed the written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Special populations that needs unique risk/benefit considerations. (Ex. Pregnant or&#xD;
             nursing women or mental disorder patients, et al.)&#xD;
&#xD;
          -  Any significant co-morbid medical condition that out of medication control. (Ex.&#xD;
             Heart/renal/hepatic failure or poorly controlled diabetes, et al.)&#xD;
&#xD;
          -  Any evidence of mechanical obstruction of the alimentary track, malabsorption, or&#xD;
             intractable vomiting.&#xD;
&#xD;
          -  Any thromboembolism event, e.g. cerebral or peripheral vascular disease&#xD;
&#xD;
          -  Judged ineligible by physicians for participation in the study due to any safety&#xD;
             concern.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hung-Ming Wang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital, Linkou, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hung-Ming Wang, M.D.</last_name>
    <phone>+886 3 3281200</phone>
    <phone_ext>8825</phone_ext>
    <email>whm526@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chia-Hsun Hsieh, M.D.</last_name>
    <phone>+886 3 3281200</phone>
    <phone_ext>2114</phone_ext>
    <email>wisdom5000@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chang-Gung Memorial Hospital, Linkou</name>
      <address>
        <city>Linkou</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Kumar NB, Kazi A, Smith T, Crocker T, Yu D, Reich RR, Reddy K, Hastings S, Exterman M, Balducci L, Dalton K, Bepler G. Cancer cachexia: traditional therapies and novel molecular mechanism-based approaches to treatment. Curr Treat Options Oncol. 2010 Dec;11(3-4):107-17. doi: 10.1007/s11864-010-0127-z.</citation>
    <PMID>21128029</PMID>
  </reference>
  <reference>
    <citation>Vadell C, Segui MA, Gimenez-Arnau JM, Morales S, Cirera L, Bestit I, Batiste E, Blanco R, Jolis L, Boleda M, Anton I. Anticachectic efficacy of megestrol acetate at different doses and versus placebo in patients with neoplastic cachexia. Am J Clin Oncol. 1998 Aug;21(4):347-51. doi: 10.1097/00000421-199808000-00006.</citation>
    <PMID>9708631</PMID>
  </reference>
  <reference>
    <citation>Pascual Lopez A, Roque i Figuls M, Urrutia Cuchi G, Berenstein EG, Almenar Pasies B, Balcells Alegre M, Herdman M. Systematic review of megestrol acetate in the treatment of anorexia-cachexia syndrome. J Pain Symptom Manage. 2004 Apr;27(4):360-9. doi: 10.1016/j.jpainsymman.2003.09.007.</citation>
    <PMID>15050664</PMID>
  </reference>
  <reference>
    <citation>Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.</citation>
    <PMID>21296615</PMID>
  </reference>
  <reference>
    <citation>Inui A. Cancer anorexia-cachexia syndrome: current issues in research and management. CA Cancer J Clin. 2002 Mar-Apr;52(2):72-91. doi: 10.3322/canjclin.52.2.72.</citation>
    <PMID>11929007</PMID>
  </reference>
  <reference>
    <citation>Maltoni M, Nanni O, Scarpi E, Rossi D, Serra P, Amadori D. High-dose progestins for the treatment of cancer anorexia-cachexia syndrome: a systematic review of randomised clinical trials. Ann Oncol. 2001 Mar;12(3):289-300. doi: 10.1023/a:1011156811739.</citation>
    <PMID>11332139</PMID>
  </reference>
  <reference>
    <citation>Beller E, Tattersall M, Lumley T, Levi J, Dalley D, Olver I, Page J, Abdi E, Wynne C, Friedlander M, Boadle D, Wheeler H, Margrie S, Simes RJ. Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: a randomised placebo-controlled trial. Australasian Megestrol Acetate Cooperative Study Group. Ann Oncol. 1997 Mar;8(3):277-83. doi: 10.1023/a:1008291825695.</citation>
    <PMID>9137798</PMID>
  </reference>
  <reference>
    <citation>De Conno F, Martini C, Zecca E, Balzarini A, Venturino P, Groff L, Caraceni A. Megestrol acetate for anorexia in patients with far-advanced cancer: a double-blind controlled clinical trial. Eur J Cancer. 1998 Oct;34(11):1705-9. doi: 10.1016/s0959-8049(98)00219-6.</citation>
    <PMID>9893656</PMID>
  </reference>
  <reference>
    <citation>Gebbia V, Testa A, Gebbia N. Prospective randomised trial of two dose levels of megestrol acetate in the management of anorexia-cachexia syndrome in patients with metastatic cancer. Br J Cancer. 1996 Jun;73(12):1576-80. doi: 10.1038/bjc.1996.297.</citation>
    <PMID>8664133</PMID>
  </reference>
  <reference>
    <citation>Loprinzi CL, Michalak JC, Schaid DJ, Mailliard JA, Athmann LM, Goldberg RM, Tschetter LK, Hatfield AK, Morton RF. Phase III evaluation of four doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia. J Clin Oncol. 1993 Apr;11(4):762-7. doi: 10.1200/JCO.1993.11.4.762.</citation>
    <PMID>8478668</PMID>
  </reference>
  <reference>
    <citation>Tchekmedyian NS, Hickman M, Siau J, Greco FA, Keller J, Browder H, Aisner J. Megestrol acetate in cancer anorexia and weight loss. Cancer. 1992 Mar 1;69(5):1268-74. doi: 10.1002/cncr.2820690532.</citation>
    <PMID>1739926</PMID>
  </reference>
  <reference>
    <citation>Tomiska M, Tomiskova M, Salajka F, Adam Z, Vorlicek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33.</citation>
    <PMID>12937858</PMID>
  </reference>
  <reference>
    <citation>Rogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084.</citation>
    <PMID>19360748</PMID>
  </reference>
  <reference>
    <citation>McRackan TR, Watkins JM, Herrin AE, Garrett-Mayer EM, Sharma AK, Day TA, Gillespie MB. Effect of body mass index on chemoradiation outcomes in head and neck cancer. Laryngoscope. 2008 Jul;118(7):1180-5. doi: 10.1097/MLG.0b013e31816fca5c.</citation>
    <PMID>18475213</PMID>
  </reference>
  <reference>
    <citation>Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25.</citation>
    <PMID>24415363</PMID>
  </reference>
  <reference>
    <citation>Capuano G, Grosso A, Gentile PC, Battista M, Bianciardi F, Di Palma A, Pavese I, Satta F, Tosti M, Palladino A, Coiro G, Di Palma M. Influence of weight loss on outcomes in patients with head and neck cancer undergoing concomitant chemoradiotherapy. Head Neck. 2008 Apr;30(4):503-8. doi: 10.1002/hed.20737.</citation>
    <PMID>18098310</PMID>
  </reference>
  <reference>
    <citation>Mantovani G, Maccio A, Bianchi A, Curreli L, Ghiani M, Santona MC, Del Giacco GS. Megestrol acetate in neoplastic anorexia/cachexia: clinical evaluation and comparison with cytokine levels in patients with head and neck carcinoma treated with neoadjuvant chemotherapy. Int J Clin Lab Res. 1995;25(3):135-41. doi: 10.1007/BF02592554.</citation>
    <PMID>8562975</PMID>
  </reference>
  <reference>
    <citation>Donohoe CL, Ryan AM, Reynolds JV. Cancer cachexia: mechanisms and clinical implications. Gastroenterol Res Pract. 2011;2011:601434. doi: 10.1155/2011/601434. Epub 2011 Jun 13.</citation>
    <PMID>21760776</PMID>
  </reference>
  <reference>
    <citation>Capozzi LC, Lau H, Reimer RA, McNeely M, Giese-Davis J, Culos-Reed SN. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial. BMC Cancer. 2012 Oct 2;12:446. doi: 10.1186/1471-2407-12-446.</citation>
    <PMID>23031071</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase II study</keyword>
  <keyword>Critical body weight loss</keyword>
  <keyword>Concurrent chemoradiotherapy</keyword>
  <keyword>Megestrol acetate</keyword>
  <keyword>Head and neck cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Megestrol</mesh_term>
    <mesh_term>Megestrol Acetate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02980653
org study id: TTYMG1403
nct id: NCT02980653
lead sponsor: 
collaborator: 
has dmc: No
Primary Objective:

      To evaluate the population prevalence of critical body weight loss ( more than 5% from
      baseline) in patients with Head and Neck cancer.

      Secondary Objectives:

      To evaluate the impact of appetite, and performance status; To evaluate the change of quality
      of life (QoL); To evaluate the incidence of infection and hospitalization; To evaluate the
      safety profiles
Hypothesis testing will be used to determine the patient number in this study. According to a
      preliminary data at CGMH-LK, the investigators have the untreated patients with population
      prevalence of critical weight loss that is 0.56, and the investigators assume the study
      treated population prevalence is 0.4, power set in 0.9, alpha set in 0.05.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Critical body weight loss
time frame: 12 weeks
description: To evaluate the population prevalence of critical body weight loss ( > 5% from baseline) in patients with Head and Neck cancer
measure: Impact of appetite
time frame: 12 weeks
description: The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study. The assessment of appetite will be performed by the visual analogue scale(VAS) within the range of 0-100mm(please refer Appendix II). The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation.
measure: Impact of performance status
time frame: 12 weeks
description: The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study. The measurement will base on ECOG performance status scale(please refer Appendix I). The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation.
measure: Change of quality of life (QoL)
time frame: 12 weeks
description: Quality of life (QOL) will be evaluated since patient registration to off study by means of the Functional Assessment of Cancer Therapy-Head and Neck (FACT-. H&N), Version 4 (Traditional Chinese) (please refer Appendix III). The questionnaire will be completed under the assistance of a trained study nurse.
measure: Incidence of infection and hospitalization
time frame: 12 weeks
description: If any patient in the study period (3 months) suffer infection or hospitalization, that should be recorded on Case Report Form for the descriptive statistics analysis.
measure: Safety profiles (percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade)
time frame: 12 weeks
description: Adverse event / toxicity assessment are based on NCI- Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03), please refer Appendix IV), and will be evaluated before the treatment, and then repeated each visit until off study. The incidence and percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade.
measure: Measurability of Anthropometric Evaluation
time frame: 12 weeks
description: Anthropometric evaluation is including body weight and body mass index.
measure: Lab test
time frame: 12 weeks
description: Lab test should be conducted every patient's visit for safety assessment. CRP and TNFα will be exanimated at screening and every 4 weeks of the treatment period.
arm group label: Megestrol
arm group type: Experimental
description: Single arm
intervention type: Drug
intervention name: Megestrol acetate (MA) 400 mg/day
description: Megestrol acetate (MA) will be given on 400 mg/day as eligible patient begin CCRT. Total treatment period is for a maximum of 12 weeks calculated from the date of first dose.
arm group label: Megestrol
other name: Megest
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hung-Ming Wang, M.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital, Linkou, Taiwan
last name: Hung-Ming Wang, M.D.
phone: +886 3 3281200
phone ext: 8825
email: whm526@gmail.com
last name: Chia-Hsun Hsieh, M.D.
phone: +886 3 3281200
phone ext: 2114
email: wisdom5000@gmail.com
facility: 
status: Recruiting
country: Taiwan
citation: Kumar NB, Kazi A, Smith T, Crocker T, Yu D, Reich RR, Reddy K, Hastings S, Exterman M, Balducci L, Dalton K, Bepler G. Cancer cachexia: traditional therapies and novel molecular mechanism-based approaches to treatment. Curr Treat Options Oncol. 2010 Dec;11(3-4):107-17. doi: 10.1007/s11864-010-0127-z.
PMID: 21128029
citation: Vadell C, Segui MA, Gimenez-Arnau JM, Morales S, Cirera L, Bestit I, Batiste E, Blanco R, Jolis L, Boleda M, Anton I. Anticachectic efficacy of megestrol acetate at different doses and versus placebo in patients with neoplastic cachexia. Am J Clin Oncol. 1998 Aug;21(4):347-51. doi: 10.1097/00000421-199808000-00006.
PMID: 9708631
citation: Pascual Lopez A, Roque i Figuls M, Urrutia Cuchi G, Berenstein EG, Almenar Pasies B, Balcells Alegre M, Herdman M. Systematic review of megestrol acetate in the treatment of anorexia-cachexia syndrome. J Pain Symptom Manage. 2004 Apr;27(4):360-9. doi: 10.1016/j.jpainsymman.2003.09.007.
PMID: 15050664
citation: Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
PMID: 21296615
citation: Inui A. Cancer anorexia-cachexia syndrome: current issues in research and management. CA Cancer J Clin. 2002 Mar-Apr;52(2):72-91. doi: 10.3322/canjclin.52.2.72.
PMID: 11929007
citation: Maltoni M, Nanni O, Scarpi E, Rossi D, Serra P, Amadori D. High-dose progestins for the treatment of cancer anorexia-cachexia syndrome: a systematic review of randomised clinical trials. Ann Oncol. 2001 Mar;12(3):289-300. doi: 10.1023/a:1011156811739.
PMID: 11332139
citation: Beller E, Tattersall M, Lumley T, Levi J, Dalley D, Olver I, Page J, Abdi E, Wynne C, Friedlander M, Boadle D, Wheeler H, Margrie S, Simes RJ. Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: a randomised placebo-controlled trial. Australasian Megestrol Acetate Cooperative Study Group. Ann Oncol. 1997 Mar;8(3):277-83. doi: 10.1023/a:1008291825695.
PMID: 9137798
citation: De Conno F, Martini C, Zecca E, Balzarini A, Venturino P, Groff L, Caraceni A. Megestrol acetate for anorexia in patients with far-advanced cancer: a double-blind controlled clinical trial. Eur J Cancer. 1998 Oct;34(11):1705-9. doi: 10.1016/s0959-8049(98)00219-6.
PMID: 9893656
citation: Gebbia V, Testa A, Gebbia N. Prospective randomised trial of two dose levels of megestrol acetate in the management of anorexia-cachexia syndrome in patients with metastatic cancer. Br J Cancer. 1996 Jun;73(12):1576-80. doi: 10.1038/bjc.1996.297.
PMID: 8664133
citation: Loprinzi CL, Michalak JC, Schaid DJ, Mailliard JA, Athmann LM, Goldberg RM, Tschetter LK, Hatfield AK, Morton RF. Phase III evaluation of four doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia. J Clin Oncol. 1993 Apr;11(4):762-7. doi: 10.1200/JCO.1993.11.4.762.
PMID: 8478668
citation: Tchekmedyian NS, Hickman M, Siau J, Greco FA, Keller J, Browder H, Aisner J. Megestrol acetate in cancer anorexia and weight loss. Cancer. 1992 Mar 1;69(5):1268-74. doi: 10.1002/cncr.2820690532.
PMID: 1739926
citation: Tomiska M, Tomiskova M, Salajka F, Adam Z, Vorlicek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33.
PMID: 12937858
citation: Rogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084.
PMID: 19360748
citation: McRackan TR, Watkins JM, Herrin AE, Garrett-Mayer EM, Sharma AK, Day TA, Gillespie MB. Effect of body mass index on chemoradiation outcomes in head and neck cancer. Laryngoscope. 2008 Jul;118(7):1180-5. doi: 10.1097/MLG.0b013e31816fca5c.
PMID: 18475213
citation: Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25.
PMID: 24415363
citation: Capuano G, Grosso A, Gentile PC, Battista M, Bianciardi F, Di Palma A, Pavese I, Satta F, Tosti M, Palladino A, Coiro G, Di Palma M. Influence of weight loss on outcomes in patients with head and neck cancer undergoing concomitant chemoradiotherapy. Head Neck. 2008 Apr;30(4):503-8. doi: 10.1002/hed.20737.
PMID: 18098310
citation: Mantovani G, Maccio A, Bianchi A, Curreli L, Ghiani M, Santona MC, Del Giacco GS. Megestrol acetate in neoplastic anorexia/cachexia: clinical evaluation and comparison with cytokine levels in patients with head and neck carcinoma treated with neoadjuvant chemotherapy. Int J Clin Lab Res. 1995;25(3):135-41. doi: 10.1007/BF02592554.
PMID: 8562975
citation: Donohoe CL, Ryan AM, Reynolds JV. Cancer cachexia: mechanisms and clinical implications. Gastroenterol Res Pract. 2011;2011:601434. doi: 10.1155/2011/601434. Epub 2011 Jun 13.
PMID: 21760776
citation: Capozzi LC, Lau H, Reimer RA, McNeely M, Giese-Davis J, Culos-Reed SN. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial. BMC Cancer. 2012 Oct 2;12:446. doi: 10.1186/1471-2407-12-446.
PMID: 23031071
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Weight Loss
mesh term: Body Weight
mesh term: Megestrol
mesh term: Megestrol Acetate