Trials / Terminated
TerminatedNCT01548534
A Randomised Study of Docosahexaenoic Acid (DHA) in Metastatic Breast Cancer
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- University Hospital, Tours · Academic / Other
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed 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.
Conditions
- Metastatic Breast Cancer
- Progesterone Receptor Positive Tumor
- Estrogen Receptor Positive Tumor
- HER-2 Negative Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DIETARY_SUPPLEMENT | Dietary supplementation with vegetable oil | Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA. |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2012-03-08
- Last updated
- 2015-07-29
Locations
11 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01548534. Inclusion in this directory is not an endorsement.