Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Judicial liquidation of the society providing dietary supplementation.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Positive Tumor | — | UNRESOLVED | — |
| HER-2 Negative Tumor | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Progesterone Receptor Positive Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary supplementation with fish oil. | Dietary Supplement | — | UNRESOLVED |
| Dietary supplementation with vegetable oil | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- DHA-free arm
- description
- Dietary supplementation with vegetable oil.
- interventionNames
- Dietary Supplement: Dietary supplementation with vegetable oil
- type
- EXPERIMENTAL
- label
- DHA arm
- description
- Dietary supplementation with fish oil.
- interventionNames
- Dietary Supplement: Dietary supplementation with fish oil.
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available