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
  Purpose

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).


Condition Intervention Phase
Metastatic Breast Cancer
Progesterone Receptor Positive Tumor
Estrogen Receptor Positive Tumor
HER-2 Negative Tumor
Dietary Supplement: Dietary supplementation with fish oil.
Dietary Supplement: Dietary supplementation with vegetable oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 212
Study Start Date: February 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: DHA-free arm
Dietary supplementation with vegetable oil.
Dietary Supplement: Dietary supplementation with vegetable oil
Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA.
Experimental: DHA arm
Dietary supplementation with fish oil.
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548534

Contacts
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

Locations
France
Institut de Cancérologie de l'Ouest (ICO) Recruiting
Angers, France, 49933
Contact: Patrick Soulié, MD       patrick.soulie@ico.unicancer.fr   
Principal Investigator: Patrick Soulié, MD         
Centre Hospitalier Jacques Coeur Not yet recruiting
Bourges, France, 18016
Contact: Christine Berger, MD       berger.christine@wanadoo.fr   
Principal Investigator: Christine Berger, MD         
CHU Morvan Not yet recruiting
Brest, France, 29609
Contact: Hélène Simon, MD       helene.simon@chu-brest.fr   
Principal Investigator: Hélène Simon, MD         
Centre François Baclesse Not yet recruiting
Caen, France, 14076
Contact: Christelle Levy, MD       c.levy@baclesse.fr   
Principal Investigator: Christelle Levy, MD         
Centre Hospitalier Not yet recruiting
Cholet, France, 49325
Contact: Alain Zannetti, MD       alain.zannetti@ch-cholet.fr   
Principal Investigator: Alain Zannetti, MD         
Centre Hospitalier Départemental Les Oudairies Not yet recruiting
La Roche Sur Yon, France, 85925
Contact: Franck Priou, MD       franck.priou@chd-vendee.fr   
Principal Investigator: Franck Priou, MD         
Centre Oscar Lambret Not yet recruiting
Lille, France, 59020
Contact: Jacques Bonneterre, MD       j-bonneterre@o-lambret.fr   
Principal Investigator: Jacques Bonneterre, MD         
Centre Hospitalier Bretagne sud Not yet recruiting
Lorient, France, 56100
Contact: Marie-Josephe Goudier, MD       mj.goudier@ch-bretagne-sud.fr   
Principal Investigator: Marie-Josephe Goudier, MD         
Clinique Guillaume de Varye Not yet recruiting
St Doulchard, France, 18230
Contact: Christine Berger, MD       berger.christine@wanadoo.fr   
Principal Investigator: Christine Berger, MD         
Centre Hospitalier Privé Not yet recruiting
St Grégoire, France, 35768
Contact: Anne Mercier-Blas, MD       amercierblas@vivalto-sante.com   
Principal Investigator: Anne Mercier-Blas, MD         
CHU Bretonneau Recruiting
Tours, France, 37044
Contact: Philippe Bougnoux, MD, PhD       bougnoux@med.univ-tours.fr   
Principal Investigator: Philippe Bougnoux, MD, PhD         
Sponsors and Collaborators
University Hospital, Tours
ICO Paul Papin
Investigators
Principal Investigator: Philippe Bougnoux, MD, PhD University Hospital, Tours
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01548534     History of Changes
Other Study ID Numbers: PHRN11-PB, 2011-A01029-32
Study First Received: February 27, 2012
Last Updated: March 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Metastatic Breast Cancer
First-Line chemotherapy
Taxane or Anthracycline
DHA
PUFA
Dietary supplementation
First-Line Taxane or Anthracycline based chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 09, 2014