A Randomised Study of Docosahexaenoic Acid (DHA) in Metastatic Breast Cancer (DHALYA)
This study is currently recruiting participants.
Verified March 2012 by University Hospital, Tours
Sponsor:
University Hospital, Tours
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fish oil
U.S. FDA Resources
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
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 May 16, 2013