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

Regional University Hospital Center (CHRU)

Status and phase

Terminated

Phase 3

Conditions

HER-2 Negative Tumor

Metastatic Breast Cancer

Estrogen Receptor Positive Tumor

Progesterone Receptor Positive Tumor

Treatments

Dietary Supplement: Dietary supplementation with fish oil.

Dietary Supplement: Dietary supplementation with vegetable oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01548534

2011-A01029-32 (Other Identifier)

PHRN11-PB

Details and patient eligibility

About

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).

Full description

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.

Enrollment

65 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.