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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University Hospital, Tours
Sponsor:
Collaborator:
ICO Paul Papin
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01548534
First received: February 27, 2012
Last updated: March 20, 2012
Last verified: March 2012

February 27, 2012
March 20, 2012
February 2012
June 2014   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
PFS is defined as time from randomization to disease progression or death.
Same as current
Complete list of historical versions of study NCT01548534 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) [ Time Frame: The best objective response from the start of treatment will be chosen. ] [ Designated as safety issue: No ]
    ORR will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
  • Overall Survival (OS) [ Time Frame: 3 years after last chemotherapy in study ] [ Designated as safety issue: No ]
    OS is defined as time from randomization to death due to any cause.
  • Time To Progression (TTP) [ Time Frame: First progression ] [ Designated as safety issue: No ]
    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).
  • Safety ans tolerance of dietary supplementation/chemotherapy association [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Incidence and severity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
  • Dietary supplementation compliance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Compliance will be assessed through patient's diary.
  • Quality Of Life (QOL) [ Time Frame: At C1, after 4 months of chemotherapy, and at the end of chemotherapy. ] [ Designated as safety issue: No ]
    QOL will be assessed by QLQ-C30 and BR23 questionnaires.
  • Pain evaluation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Pain will be assessed by a Visual Analog Scale (VAS) and analgesic consumption.
  • DHA plasma level [ Time Frame: Before dietary supplementation (at C1), and after 4 months of dietary supplementation. ] [ Designated as safety issue: No ]
    Plasma phospholipids DHA incorporation will be measured with a blood sample.
  • Neuropathy evaluation [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Neuropathy will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Metastatic Breast Cancer
  • Progesterone Receptor Positive Tumor
  • Estrogen Receptor Positive Tumor
  • HER-2 Negative Tumor
  • 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.
  • Placebo Comparator: DHA-free arm
    Dietary supplementation with vegetable oil.
    Intervention: Dietary Supplement: Dietary supplementation with vegetable oil
  • Experimental: DHA arm
    Dietary supplementation with fish oil.
    Intervention: Dietary Supplement: Dietary supplementation with fish oil.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
212
June 2017
June 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 80 Years
No
Contact: Virginie Berger, MD, PhD 33 2 41 35 27 34 virginie.berger@ico.unicancer.fr
Contact: Jessy Delaye, M Sc 33 2 41 35 29 31 jessy.delaye@ico.unicancer.fr
France
 
NCT01548534
PHRN11-PB, 2011-A01029-32
No
University Hospital, Tours
University Hospital, Tours
ICO Paul Papin
Principal Investigator: Philippe Bougnoux, MD, PhD University Hospital, Tours
University Hospital, Tours
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP