A Randomised Study of Docosahexaenoic Acid (DHA) in Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Metastatic Breast Cancer Progesterone Receptor Positive Tumor Estrogen Receptor Positive Tumor HER-2 Negative Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DHA-free arm

Dietary supplementation with vegetable oil.

Group Type PLACEBO_COMPARATOR

Dietary supplementation with vegetable oil

Intervention Type DIETARY_SUPPLEMENT

Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA.

DHA arm

Dietary supplementation with fish oil.

Group Type EXPERIMENTAL

Dietary supplementation with fish oil.

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Dietary supplementation with vegetable oil

Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No