Clinical trial NCT01548534: A Randomised Study of Docosahexaenoic Acid (DHA) in Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Progesterone Receptor Positive Tumor
Estrogen Receptor Positive Tumor
HER-2 Negative Tumor
Keywords: Metastatic Breast Cancer
First-Line chemotherapy
Taxane or Anthracycline
DHA
PUFA
Dietary supplementation
First-Line Taxane or Anthracycline based chemotherapy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut Cancerologie de l'Ouest
First posted: 2012-03-08
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 4 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: The objective response is the best objective response observed from the start of treatment to progression.
measure: Overall Survival (OS)
timeFrame: 3 years after last chemotherapy in study
measure: Time To Progression (TTP)
timeFrame: First progression
measure: Safety ans tolerance of dietary supplementation/chemotherapy association
timeFrame: 4 months
measure: Dietary supplementation compliance
timeFrame: 4 months
measure: Quality Of Life (QOL)
timeFrame: At C1, after 4 months of chemotherapy, and at the end of chemotherapy.
measure: Pain evaluation
timeFrame: 4 months
measure: DHA plasma level
timeFrame: Before dietary supplementation (at C1), and after 4 months of dietary supplementation.
measure: Neuropathy evaluation
timeFrame: 4 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest (ICO)
city: Bourges
country: France
facility: Centre Hospitalier Jacques Coeur
city: Brest
country: France
facility: CHU Morvan
city: Caen
country: France
facility: Centre François Baclesse
city: Cholet
country: France
facility: Centre Hospitalier
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Départemental Les Oudairies
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: Centre Hospitalier Bretagne sud
city: St Doulchard
country: France
facility: Clinique Guillaume de Varye
city: St Grégoire
country: France
facility: Centre Hospitalier Privé
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
affiliation: University Hospital, Tours
name: Philippe Bougnoux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: