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

Metastatic Breast Cancer Clinical Trial

— DHALYA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01548534
• Other study ID #: PHRN11-PB
• Secondary ID: 2011-A01029-32
• Status: Terminated
• Phase: Phase 3
• First received: February 27, 2012
• Last updated: July 28, 2015
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Estrogen Receptor Positive Tumor
• HER-2 Negative Tumor
• Metastatic Breast Cancer
• Progesterone Receptor Positive Tumor

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest (ICO)	Angers
France	Centre Hospitalier Jacques Coeur	Bourges
France	CHU Morvan	Brest
France	Centre François Baclesse	Caen
France	Centre Hospitalier	Cholet
France	Centre Hospitalier Départemental Les Oudairies	La Roche Sur Yon
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier Bretagne sud	Lorient
France	Clinique Guillaume de Varye	St Doulchard
France	Centre Hospitalier Privé	St Grégoire
France	CHU Bretonneau	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	ICO Paul Papin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS is defined as time from randomization to disease progression or death.	4 months	No
Secondary	Objective Response Rate (ORR)	ORR will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).	The objective response is the best objective response observed from the start of treatment to progression.	No
Secondary	Overall Survival (OS)	OS is defined as time from randomization to death due to any cause.	3 years after last chemotherapy in study	No
Secondary	Time To Progression (TTP)	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).	First progression	No
Secondary	Safety ans tolerance of dietary supplementation/chemotherapy association	Incidence and severity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.	4 months	Yes
Secondary	Dietary supplementation compliance	Compliance will be assessed through patient's diary.	4 months	No
Secondary	Quality Of Life (QOL)	QOL will be assessed by QLQ-C30 and BR23 questionnaires.	At C1, after 4 months of chemotherapy, and at the end of chemotherapy.	No
Secondary	Pain evaluation	Pain will be assessed by a Visual Analog Scale (VAS) and analgesic consumption.	4 months	No
Secondary	DHA plasma level	Plasma phospholipids DHA incorporation will be measured with a blood sample.	Before dietary supplementation (at C1), and after 4 months of dietary supplementation.	No
Secondary	Neuropathy evaluation	Neuropathy will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.	4 months	Yes