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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Progression Free Survival (PFS)
PFS is defined as time from randomization to disease progression or death.
Philippe Bougnoux, MD, PhD
University Hospital, Tours
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)