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

Phase 3

Terminated

• Conditions: Metastatic Breast Cancer; HER-2 Negative Tumor; Progesterone Receptor Positive Tumor; Estrogen Receptor Positive Tumor
• Interventions: Dietary Supplement: Dietary supplementation with vegetable oil; Dietary Supplement: Dietary supplementation with fish oil.

• Registration Number: NCT01548534
• Lead Sponsor: University Hospital, Tours

Brief 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA-free arm	Dietary supplementation with vegetable oil	Dietary supplementation with vegetable oil.
DHA arm	Dietary supplementation with fish oil.	Dietary supplementation with fish oil.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	4 months	PFS is defined as time from randomization to disease progression or death.

Secondary Outcome Measures

Name	Time	Method
DHA plasma level	Before dietary supplementation (at C1), and after 4 months of dietary supplementation.	Plasma phospholipids DHA incorporation will be measured with a blood sample.
Objective Response Rate (ORR)	The objective response is the best objective response observed from the start of treatment to progression.	ORR will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Time To Progression (TTP)	First progression	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).
Pain evaluation	4 months	Pain will be assessed by a Visual Analog Scale (VAS) and analgesic consumption.
Neuropathy evaluation	4 months	Neuropathy will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Safety ans tolerance of dietary supplementation/chemotherapy association	4 months	Incidence and severity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Quality Of Life (QOL)	At C1, after 4 months of chemotherapy, and at the end of chemotherapy.	QOL will be assessed by QLQ-C30 and BR23 questionnaires.
Overall Survival (OS)	3 years after last chemotherapy in study	OS is defined as time from randomization to death due to any cause.
Dietary supplementation compliance	4 months	Compliance will be assessed through patient's diary.

Trial Locations

Locations (11)

Centre Hospitalier Jacques Coeur; 🇫🇷 Bourges, France

Institut de Cancérologie de l'Ouest (ICO); 🇫🇷 Angers, France

CHU Morvan; 🇫🇷 Brest, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Hospitalier; 🇫🇷 Cholet, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Hospitalier Départemental Les Oudairies; 🇫🇷 La Roche Sur Yon, France

Clinique Guillaume de Varye; 🇫🇷 St Doulchard, France

CHU Bretonneau; 🇫🇷 Tours, France

Centre Hospitalier Bretagne sud; 🇫🇷 Lorient, France

Centre Hospitalier Privé; 🇫🇷 St Grégoire, France