<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/NCT03831178</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-0005</org_study_id>
    <nct_id>NCT03831178</nct_id>
  </id_info>
  <brief_title>Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting</brief_title>
  <acronym>DHA-WIN</acronym>
  <official_title>Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AHS Cancer Control Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AHS Cancer Control Alberta</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>
      Docosahexaenoic acid (DHA) is an omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA).&#xD;
      N-3 LCPUFA are essential fatty acids in the diet. The majority of n-3 LCPUFA in the diet is&#xD;
      alpha-linolenic acid (ALA). While DHA can be synthesized from ALA and other n-3 LCPUFA in the&#xD;
      body, endogenous synthesis is low. Consequently, the only way to significantly increase&#xD;
      levels of DHA in tissues is by directly consuming this fatty acid. Common sources of DHA are&#xD;
      fatty fish, fish oil and omega-3 supplements and fortified foods.&#xD;
&#xD;
      DHA is readily incorporated into membrane phospholipids and induces changes in the properties&#xD;
      of the cell membrane including altered fluidity; permeability and membrane transport as well&#xD;
      as activity of membrane bound receptors and enzymes.&#xD;
&#xD;
      It is well established that changes in membrane DHA has multiple effects in the body,&#xD;
      including modulation of neurological, immune, and cardiovascular functions. In breast cancer,&#xD;
      DHA increases sensitivity of breast cancer cells to different chemotherapeutic agents, and in&#xD;
      animal models of breast cancer, dietary DHA decreases tumour growth. The investigator's&#xD;
      preclinical studies demonstrate that DHA increases efficacy of both doxorubicin and&#xD;
      docetaxel, two agents commonly used in the adjuvant setting for breast cancer treatment.&#xD;
      Furthermore, DHA mitigates chemotherapy induced weight loss in mice, and reduces paclitaxel&#xD;
      toxicities in breast cancer patients, strongly indicating that DHA protects against toxicity&#xD;
      in normal tissues. Directly relevant to this study, increased DHA in breast adipose tissue&#xD;
      correlates with improved response to chemotherapy, and increased dietary intake of n-3&#xD;
      LCPUFA, including DHA, results in increased DHA incorporation in breast adipose tissue.&#xD;
      Lastly, in advanced metastatic breast cancer, DHA supplementation correlated with improved&#xD;
      outcomes in a subset of patients. Consequently, the Investigators hypothesize that the&#xD;
      therapeutic index (efficacy: toxicity ratio) will be improved with the addition of DHA. In&#xD;
      this clinical trial, the Investigators will explore the benefit of DHA supplementation in&#xD;
      combination with neoadjuvant chemotherapy in patients with early breast cancer.&#xD;
&#xD;
      RESEARCH QUESTION &amp; OBJECTIVES: The Investigators propose to evaluate incorporation of DHA in&#xD;
      women with breast cancer in treatment naïve patients in combination with chemotherapy, and&#xD;
      assess potential benefit of DHA supplementation in breast cancer patients, using change in&#xD;
      Ki67 labeling index (marker of proliferation) as a marker of efficacy. This study will&#xD;
      further investigate the relationship between DHA in plasma phospholipids (as a potential&#xD;
      biomarker of tumour incorporation) and effect on systemic immune function.&#xD;
&#xD;
      METHODS: Patients directed to receive chemotherapy will receive capsules, each containing a&#xD;
      minimum of 400 mg of DHA in the form of DHA enriched triglyceride oil or placebo (corn/soy&#xD;
      oil blend) to be taken orally (11 capsules/day, throughout day as preferred by participant)&#xD;
      for a total of 5 g DHA or placebo, for 12-18 weeks (84-126 days) beginning at the start of&#xD;
      the first cycle of chemotherapy, and continued throughout 4-6 cycles of chemotherapy (3&#xD;
      weeks/ cycle). DHA will be discontinued 21 days after the last administration of cytotoxic&#xD;
      chemotherapy. Tumour biopsies at baseline and post surgical removal will be assessed for Ki67&#xD;
      status as well as for markers of apoptosis and stem cell presence (by immunohistochemistry).&#xD;
      Blood samples taken at baseline prior to each round of chemotherapy will be assessed for&#xD;
      immune markers and plasma phospholipid content.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in Ki67 index from baseline to surgical excision.</measure>
    <time_frame>Pre-intervention (on the baseline biopsy) and post- intervention (at the time of surgical excision).</time_frame>
    <description>Ki67 will be measured by image analysis at baseline biopsy and at experimental end (surgical excision).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of DHA in plasma phospholipids between DHA and placebo arms.</measure>
    <time_frame>At day 0 and day 20 of cycles 1 to 6 of chemotherapy (each cycle is 20 days).</time_frame>
    <description>Changes in level of DHA incorporation in plasma phospholipids will be assessed to identify the range of DHA incorporation in this patient population. Fatty acid composition of plasma phospholipids will be measured after lipid extraction, phospholipid separation on thin layer chromatography followed by methylation and separation identification by gas-liquid chromatography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in immune function (e.g. ability to produce IL-2 after stimulation) following DHA supplementation in combination with chemotherapy.</measure>
    <time_frame>Baseline (within 21 days before cycle 1 of chemotherapy) and at the end of chemotherapy cycle 3 (each cyle is 20 days)</time_frame>
    <description>Systemic immune function will be assessed on stored plasma by U-PLEX Biomarker Group 1 electrochemiluminescent multiplex assays (MesoScale Discovery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age of participants and other factors affecting DHA incorporation</measure>
    <time_frame>Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).</time_frame>
    <description>If incorporation of DHA in plasma phospholipids is variable within the DHA treatment arm, possible factors that may influence incorporation (e.g. age of participants) will be explored between high and low incorporators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change on markers of apoptosis (e.g. caspase-3) following DHA or placebo supplementation.</measure>
    <time_frame>Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).</time_frame>
    <description>Breast tissue from participants receiving DHA or placebo will be assessed for markers of apoptosis (e.g. caspase-3) by immunohistochemistry and calculated by image analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological complete response rate</measure>
    <time_frame>Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).</time_frame>
    <description>Pathological complete response in resected breast tissue and all sampled axillary nodes will be assessed as absence of invasive cancer on haematoxylin and eosin evaluation as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of rate of chemotherapy associated grade 3 and 4 toxicities between treatment arms.</measure>
    <time_frame>At day 20 of chemotherapy cycles 1 to 6 (each cycle is 20 days).</time_frame>
    <description>Rate of chemotherapy associated grade 3 and 4 toxicities, and chemotherapy- associated hospitalizations will be compared between DHA and placebo arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>DHA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take 11 capsules per day containing DHA-enriched triglyceride oil (1 g capsules containing at least 400 mg DHA) for a total of 5 g DHA/day divided into three times daily with meals or as tolerated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take 11 capsules per day containing corn/soy oil blend capsules divided into three times daily with meals or as tolerated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Docosahexaenoic acid (DHA)</intervention_name>
    <description>Participants will take 11 capsules of DHA oil for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.</description>
    <arm_group_label>DHA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Participants will take 11 capsules of placebo (corn/soy oil blend) for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with invasive (clinical stage I, II and III) breast cancer, for whom neoadjuvant&#xD;
             systemic therapy with chemotherapy is recommended prior to surgery.&#xD;
&#xD;
          2. ECOG Performance status of 0 or 1.&#xD;
&#xD;
          3. Hematology and Biochemistry assessments (CBC and differential, PTT, PT/INR, AST, Alk&#xD;
             Phos, Bilirubin, and Creatinine) within normal range unless determined not clinically&#xD;
             significant by the qualified investigator.&#xD;
&#xD;
          4. Ability to take oral medications.&#xD;
&#xD;
          5. Adequate tissue specimen for diagnosis, biomarkers, and endpoint Ki67 assays.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing surgery prior to chemotherapy.&#xD;
&#xD;
          2. Current or previous (within 2 months) daily use (&gt;1 day/week) use of omega-3, fish&#xD;
             oil, or other supplements or functional foods containing docosahexaenoic acid (at&#xD;
             daily doses &gt; 200 mg).&#xD;
&#xD;
          3. Known allergy to soy or corn.&#xD;
&#xD;
          4. Continued intake of supplements containing Vitamin C, Vitamin E or β-carotene&#xD;
             exceeding the DRI, or other anti-oxidant supplements.&#xD;
&#xD;
          5. Symptomatic but untreated cholelithiasis.&#xD;
&#xD;
          6. History of deep venous thrombosis, active thrombophlebitis, pulmonary embolism,&#xD;
             stroke, acute myocardial infarction, congestive cardiac failure, untreated&#xD;
             hypertension, known inherited hypercoagulable disorder.&#xD;
&#xD;
          7. Diagnosis of any other malignancy within the previous year except for adequately&#xD;
             treated basal cell or squamous cell skin cancer.&#xD;
&#xD;
          8. Medically documented history of a psychiatric disorder that would preclude consent&#xD;
&#xD;
          9. Partial or complete loss of vision or diplopia, from ophthalmic vascular disease.&#xD;
&#xD;
         10. Hypersensitivity to DHA or to any ingredient in the formulation or component of the&#xD;
             container.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Mackey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cross Cancer Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deborah Miede, RN</last_name>
    <phone>780-432-8644</phone>
    <email>Deborah.Miede@albertahealthservices.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>John Mackey, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Newell M, Mackey JR, Bigras G, Alvarez-Camacho M, Goruk S, Ghosh S, Schmidt A, Miede D, Chisotti A, Postovit L, Baker K, Mazurak V, Courneya K, Berendt R, Dong WF, Wood G, Basi SK, Joy AA, King K, Meza-Junco J, Zhu X, Field C. Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial. BMJ Open. 2019 Sep 17;9(9):e030502. doi: 10.1136/bmjopen-2019-030502.</citation>
    <PMID>31530611</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Cross Cancer Institute and the University of Alberta encourages and supports the responsible and ethical sharing of data from clinical trials. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Documents will be published within 6 months after starting the trial.</ipd_time_frame>
  </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/NCT03831178
org study id: IIT-0005
nct id: NCT03831178
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Docosahexaenoic acid (DHA) is an omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA).
      N-3 LCPUFA are essential fatty acids in the diet. The majority of n-3 LCPUFA in the diet is
      alpha-linolenic acid (ALA). While DHA can be synthesized from ALA and other n-3 LCPUFA in the
      body, endogenous synthesis is low. Consequently, the only way to significantly increase
      levels of DHA in tissues is by directly consuming this fatty acid. Common sources of DHA are
      fatty fish, fish oil and omega-3 supplements and fortified foods.

      DHA is readily incorporated into membrane phospholipids and induces changes in the properties
      of the cell membrane including altered fluidity; permeability and membrane transport as well
      as activity of membrane bound receptors and enzymes.

      It is well established that changes in membrane DHA has multiple effects in the body,
      including modulation of neurological, immune, and cardiovascular functions. In breast cancer,
      DHA increases sensitivity of breast cancer cells to different chemotherapeutic agents, and in
      animal models of breast cancer, dietary DHA decreases tumour growth. The investigator's
      preclinical studies demonstrate that DHA increases efficacy of both doxorubicin and
      docetaxel, two agents commonly used in the adjuvant setting for breast cancer treatment.
      Furthermore, DHA mitigates chemotherapy induced weight loss in mice, and reduces paclitaxel
      toxicities in breast cancer patients, strongly indicating that DHA protects against toxicity
      in normal tissues. Directly relevant to this study, increased DHA in breast adipose tissue
      correlates with improved response to chemotherapy, and increased dietary intake of n-3
      LCPUFA, including DHA, results in increased DHA incorporation in breast adipose tissue.
      Lastly, in advanced metastatic breast cancer, DHA supplementation correlated with improved
      outcomes in a subset of patients. Consequently, the Investigators hypothesize that the
      therapeutic index (efficacy: toxicity ratio) will be improved with the addition of DHA. In
      this clinical trial, the Investigators will explore the benefit of DHA supplementation in
      combination with neoadjuvant chemotherapy in patients with early breast cancer.

      RESEARCH QUESTION & OBJECTIVES: The Investigators propose to evaluate incorporation of DHA in
      women with breast cancer in treatment naïve patients in combination with chemotherapy, and
      assess potential benefit of DHA supplementation in breast cancer patients, using change in
      Ki67 labeling index (marker of proliferation) as a marker of efficacy. This study will
      further investigate the relationship between DHA in plasma phospholipids (as a potential
      biomarker of tumour incorporation) and effect on systemic immune function.

      METHODS: Patients directed to receive chemotherapy will receive capsules, each containing a
      minimum of 400 mg of DHA in the form of DHA enriched triglyceride oil or placebo (corn/soy
      oil blend) to be taken orally (11 capsules/day, throughout day as preferred by participant)
      for a total of 5 g DHA or placebo, for 12-18 weeks (84-126 days) beginning at the start of
      the first cycle of chemotherapy, and continued throughout 4-6 cycles of chemotherapy (3
      weeks/ cycle). DHA will be discontinued 21 days after the last administration of cytotoxic
      chemotherapy. Tumour biopsies at baseline and post surgical removal will be assessed for Ki67
      status as well as for markers of apoptosis and stem cell presence (by immunohistochemistry).
      Blood samples taken at baseline prior to each round of chemotherapy will be assessed for
      immune markers and plasma phospholipid content.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent change in Ki67 index from baseline to surgical excision.
time frame: Pre-intervention (on the baseline biopsy) and post- intervention (at the time of surgical excision).
description: Ki67 will be measured by image analysis at baseline biopsy and at experimental end (surgical excision).
measure: Percent of DHA in plasma phospholipids between DHA and placebo arms.
time frame: At day 0 and day 20 of cycles 1 to 6 of chemotherapy (each cycle is 20 days).
description: Changes in level of DHA incorporation in plasma phospholipids will be assessed to identify the range of DHA incorporation in this patient population. Fatty acid composition of plasma phospholipids will be measured after lipid extraction, phospholipid separation on thin layer chromatography followed by methylation and separation identification by gas-liquid chromatography.
measure: Change in immune function (e.g. ability to produce IL-2 after stimulation) following DHA supplementation in combination with chemotherapy.
time frame: Baseline (within 21 days before cycle 1 of chemotherapy) and at the end of chemotherapy cycle 3 (each cyle is 20 days)
description: Systemic immune function will be assessed on stored plasma by U-PLEX Biomarker Group 1 electrochemiluminescent multiplex assays (MesoScale Discovery).
measure: Age of participants and other factors affecting DHA incorporation
time frame: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
description: If incorporation of DHA in plasma phospholipids is variable within the DHA treatment arm, possible factors that may influence incorporation (e.g. age of participants) will be explored between high and low incorporators.
measure: Percent change on markers of apoptosis (e.g. caspase-3) following DHA or placebo supplementation.
time frame: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
description: Breast tissue from participants receiving DHA or placebo will be assessed for markers of apoptosis (e.g. caspase-3) by immunohistochemistry and calculated by image analysis.
measure: Pathological complete response rate
time frame: Once participants undergo their breast surgery (within 3-6 weeks after the last chemotherapy cycle, each cycle is 20 days).
description: Pathological complete response in resected breast tissue and all sampled axillary nodes will be assessed as absence of invasive cancer on haematoxylin and eosin evaluation as per standard of care.
measure: Comparison of rate of chemotherapy associated grade 3 and 4 toxicities between treatment arms.
time frame: At day 20 of chemotherapy cycles 1 to 6 (each cycle is 20 days).
description: Rate of chemotherapy associated grade 3 and 4 toxicities, and chemotherapy- associated hospitalizations will be compared between DHA and placebo arms.
arm group label: DHA
arm group type: Experimental
description: Participants will take 11 capsules per day containing DHA-enriched triglyceride oil (1 g capsules containing at least 400 mg DHA) for a total of 5 g DHA/day divided into three times daily with meals or as tolerated.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will take 11 capsules per day containing corn/soy oil blend capsules divided into three times daily with meals or as tolerated.
intervention type: Dietary Supplement
intervention name: Docosahexaenoic acid (DHA)
description: Participants will take 11 capsules of DHA oil for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.
arm group label: DHA
intervention type: Drug
intervention name: Placebo oral capsule
description: Participants will take 11 capsules of placebo (corn/soy oil blend) for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Mackey, MD
role: Principal Investigator
affiliation: Cross Cancer Institute
last name: Deborah Miede, RN
phone: 780-432-8644
email: Deborah.Miede@albertahealthservices.ca
facility: 
status: Recruiting
investigator: 
country: Canada
citation: Newell M, Mackey JR, Bigras G, Alvarez-Camacho M, Goruk S, Ghosh S, Schmidt A, Miede D, Chisotti A, Postovit L, Baker K, Mazurak V, Courneya K, Berendt R, Dong WF, Wood G, Basi SK, Joy AA, King K, Meza-Junco J, Zhu X, Field C. Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial. BMJ Open. 2019 Sep 17;9(9):e030502. doi: 10.1136/bmjopen-2019-030502.
PMID: 31530611
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: The Cross Cancer Institute and the University of Alberta encourages and supports the responsible and ethical sharing of data from clinical trials. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Documents will be published within 6 months after starting the trial.