A Randomised Study of Docosahexaenoic Acid (DHA) in Metastatic Breast Cancer (DHALYA)
|Metastatic Breast Cancer Progesterone Receptor Positive Tumor Estrogen Receptor Positive Tumor HER-2 Negative Tumor||Dietary Supplement: Dietary supplementation with fish oil. Dietary Supplement: Dietary supplementation with vegetable oil||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||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|
- Progression Free Survival (PFS) [ Time Frame: 4 months ]PFS is defined as time from randomization to disease progression or death.
- Objective Response Rate (ORR) [ Time Frame: The objective response is the best objective response observed from the start of treatment to progression. ]ORR will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- Overall Survival (OS) [ Time Frame: 3 years after last chemotherapy in study ]OS is defined as time from randomization to death due to any cause.
- Time To Progression (TTP) [ Time Frame: First progression ]TTP is defined as time from randomization to first documentation of objective tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- Safety ans tolerance of dietary supplementation/chemotherapy association [ Time Frame: 4 months ]Incidence and severity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
- Dietary supplementation compliance [ Time Frame: 4 months ]Compliance will be assessed through patient's diary.
- Quality Of Life (QOL) [ Time Frame: At C1, after 4 months of chemotherapy, and at the end of chemotherapy. ]QOL will be assessed by QLQ-C30 and BR23 questionnaires.
- Pain evaluation [ Time Frame: 4 months ]Pain will be assessed by a Visual Analog Scale (VAS) and analgesic consumption.
- DHA plasma level [ Time Frame: Before dietary supplementation (at C1), and after 4 months of dietary supplementation. ]Plasma phospholipids DHA incorporation will be measured with a blood sample.
- Neuropathy evaluation [ Time Frame: 4 months ]Neuropathy will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
|Study Start Date:||February 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: DHA-free arm
Dietary supplementation with vegetable oil.
Dietary Supplement: Dietary supplementation with vegetable oil
Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA.
Experimental: DHA arm
Dietary supplementation with fish oil.
Dietary Supplement: Dietary supplementation with fish oil.
Patients randomized in this arm will take 3 cans/day with fish oil : DHA is 1.56 g/d and EPA is 2.64 g/d.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548534
|Institut de Cancérologie de l'Ouest (ICO)|
|Angers, France, 49933|
|Centre Hospitalier Jacques Coeur|
|Bourges, France, 18016|
|Brest, France, 29609|
|Centre François Baclesse|
|Caen, France, 14076|
|Cholet, France, 49325|
|Centre Hospitalier Départemental Les Oudairies|
|La Roche Sur Yon, France, 85925|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Hospitalier Bretagne sud|
|Lorient, France, 56100|
|Clinique Guillaume de Varye|
|St Doulchard, France, 18230|
|Centre Hospitalier Privé|
|St Grégoire, France, 35768|
|Tours, France, 37044|
|Principal Investigator:||Philippe Bougnoux, MD, PhD||University Hospital, Tours|