A Phase III Randomized, Multicenter, Two Arms Double-blind Trial Versus Placebo, Evaluating the Interest of a Dietary Supplementation With Docosahexaenoic Acid (DHA) During Chemotherapy for Metastatic Breast Cancer
18 Years
80 Years
Female
Metastatic Breast Cancer, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor, HER-2 Negative Tumor
Trial Information
A Phase III Randomized, Multicenter, Two Arms Double-blind Trial Versus Placebo, Evaluating the Interest of a Dietary Supplementation With Docosahexaenoic Acid (DHA) During Chemotherapy for Metastatic Breast Cancer
Local relapses and metastases make breast cancer a deadly disease. A major goal remains the
improvement of treatment efficacy, meaning increasing toxicity to tumor tissue, without
additional toxicity to non-tumor tissues.
The literature indicates that DHA sensitizes breast malignant tumors, but not non-tumor
tissues, to chemotherapy and to radiotherapy through a variety of mechanisms. DHA enrichment
of tissues can be achieved through a dietary supplementation of DHA-containing oils, such as
fish oil, both in experimental animal models or in humans. Therefore, this represents an
original nutritional approach to increase the activity of anticancer treatments through an
enhanced specificity toward tumor tissues.
Inclusion Criteria:
- Metastatic breast cancer requiring first-line taxanes or anthracyclines based
chemotherapy
- HER2 negative, HR positive
- Life expectancy > 3 months
- ECOG Performance Status < or = 2 within 15 days before randomization
- Measurable and/or evaluable disease according to RECIST criteria 1.1
- Age > or = 18 years and < or = 80 years
- Body Mass Index (BMI)>17 for patients < 70 years and BMI>21 for patients > 70 years,
within 15 days before randomization
- Hepatic parameters : total bilirubin strictly normal, AST and ALT < or = 3xULN (5 if
liver metastases) within 15 days before randomization
- Signed written informed consent
Exclusion Criteria:
- Triple negative breast cancer or HER2 over expression
- Symptomatic central nervous system metastases
- Previous chemotherapy for metastatic breast cancer
- Obesity with BMI > 35 within 15 days before randomization
- Presence of another invasive cancer
- Uncontrolled Cardiac disease or uncontrolled hypertension
- Milk protein intolerance
- Known food allergy to fish
- Women of childbearing potential not using adequate contraceptive measures, pregnant
or breast feeding.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Progression Free Survival (PFS)
Outcome Description:
PFS is defined as time from randomization to disease progression or death.
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Philippe Bougnoux, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Tours
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
PHRN11-PB
NCT ID:
NCT01548534
Start Date:
February 2012
Completion Date:
June 2017
Related Keywords:
- Metastatic Breast Cancer
- Progesterone Receptor Positive Tumor
- Estrogen Receptor Positive Tumor
- HER-2 Negative Tumor
- Metastatic Breast Cancer
- First-Line chemotherapy
- Taxane or Anthracycline
- DHA
- PUFA
- Dietary supplementation
- First-Line Taxane or Anthracycline based chemotherapy
- Breast Neoplasms
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