NCT01548534

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

2.3 years

First QC Date

February 27, 2012

Last Update Submit

July 28, 2015

Conditions

Metastatic Breast CancerProgesterone Receptor Positive TumorEstrogen Receptor Positive TumorHER-2 Negative Tumor

Keywords

Metastatic Breast CancerFirst-Line chemotherapyTaxane or AnthracyclineDHAPUFADietary supplementationFirst-Line Taxane or Anthracycline based chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    PFS is defined as time from randomization to disease progression or death.

    4 months

Secondary Outcomes (9)

  • Objective Response Rate (ORR)

    The objective response is the best objective response observed from the start of treatment to progression.

  • Overall Survival (OS)

    3 years after last chemotherapy in study

  • Time To Progression (TTP)

    First progression

  • Safety ans tolerance of dietary supplementation/chemotherapy association

    4 months

  • Dietary supplementation compliance

    4 months

  • +4 more secondary outcomes

Study Arms (2)

DHA-free arm

PLACEBO COMPARATOR

Dietary supplementation with vegetable oil.

Dietary Supplement: Dietary supplementation with vegetable oil

DHA arm

EXPERIMENTAL

Dietary supplementation with fish oil.

Dietary Supplement: Dietary supplementation with fish oil.

Interventions

Dietary supplementation with fish oil.DIETARY_SUPPLEMENT

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.

DHA arm
Dietary supplementation with vegetable oilDIETARY_SUPPLEMENT

Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA.

DHA-free arm

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Institut de Cancérologie de l'Ouest (ICO)

Angers, 49933, France

Location

Centre Hospitalier Jacques Coeur

Bourges, 18016, France

Location

CHU Morvan

Brest, 29609, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Hospitalier

Cholet, 49325, France

Location

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier Bretagne sud

Lorient, 56100, France

Location

Clinique Guillaume de Varye

Saint-Doulchard, 18230, France

Location

Centre Hospitalier Privé

Saint-Grégoire, 35768, France

Location

CHU Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dietary SupplementsFish OilsPlant Oils

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Philippe Bougnoux, MD, PhD

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 8, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

FR(11)