The aim of this study is to increase, by DHA-induced chemosensitization, the activity of anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
65
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.
Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA.
Institut de Cancérologie de l'Ouest (ICO)
Angers, France
Centre Hospitalier Jacques Coeur
Bourges, France
CHU Morvan
Brest, France
Centre François Baclesse
Progression Free Survival (PFS)
PFS is defined as time from randomization to disease progression or death.
Time frame: 4 months
Objective Response Rate (ORR)
ORR will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Time frame: The objective response is the best objective response observed from the start of treatment to progression.
Overall Survival (OS)
OS is defined as time from randomization to death due to any cause.
Time frame: 3 years after last chemotherapy in study
Time To Progression (TTP)
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).
Time frame: First progression
Safety ans tolerance of dietary supplementation/chemotherapy association
Incidence and severity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: 4 months
Dietary supplementation compliance
Compliance will be assessed through patient's diary.
Time frame: 4 months
Quality Of Life (QOL)
QOL will be assessed by QLQ-C30 and BR23 questionnaires.
Time frame: At C1, after 4 months of chemotherapy, and at the end of chemotherapy.
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Caen, France
Centre Hospitalier
Cholet, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France
Centre Oscar Lambret
Lille, France
Centre Hospitalier Bretagne sud
Lorient, France
Clinique Guillaume de Varye
Saint-Doulchard, France
Centre Hospitalier Privé
Saint-Grégoire, France
...and 1 more locations
Pain evaluation
Pain will be assessed by a Visual Analog Scale (VAS) and analgesic consumption.
Time frame: 4 months
DHA plasma level
Plasma phospholipids DHA incorporation will be measured with a blood sample.
Time frame: Before dietary supplementation (at C1), and after 4 months of dietary supplementation.
Neuropathy evaluation
Neuropathy will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: 4 months