Metastatic Breast CancerPhase 3DHALYANCT01548534

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

A Phase 3 study testing Dietary supplementation with fish oil. and Dietary supplementation with vegetable oil in people with Metastatic Breast Cancer and Progesterone Receptor Positive Tumor, run by University Hospital, Tours at 11 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Metastatic Breast Cancer, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor
What is being tested?: Dietary supplementation with fish oil. and Dietary supplementation with vegetable oil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 11 sitesFrance
Study dates: Feb 2012to Jun 2014
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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Milk protein intolerance
Known food allergy to fish
Women of childbearing potential not using adequate contraceptive measures, pregnant or breast feeding.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

France11 sites

Institut de Cancérologie de l'Ouest (ICO)
Angers, 49933
Centre Hospitalier Jacques Coeur
Bourges, 18016
CHU Morvan
Brest, 29609
Centre François Baclesse
Caen, 14076
Centre Hospitalier
Cholet, 49325
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, 85925
Centre Oscar Lambret
Lille, 59020
Centre Hospitalier Bretagne sud
Lorient, 56100
Clinique Guillaume de Varye
Saint-Doulchard, 18230
Centre Hospitalier Privé
Saint-Grégoire, 35768
CHU Bretonneau
Tours, 37044

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About this study

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

Read the 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.

Conditions: Metastatic Breast Cancer, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor, HER-2 Negative Tumor
Being tested: Dietary supplementation with fish oil., Dietary supplementation with vegetable oil
Keywords: Metastatic Breast Cancer, First-Line chemotherapy, Taxane or Anthracycline, DHA, PUFA, Dietary supplementation, First-Line Taxane or Anthracycline based chemotherapy
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01548534
Study group	Role	What they receive
DHA-free arm	Placebo comparator	Dietary supplementation with vegetable oil. Receives: Dietary Supplement: Dietary supplementation with vegetable oil
DHA arm	Experimental	Dietary supplementation with fish oil. Receives: Dietary Supplement: Dietary supplementation with fish oil.

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
PFS is defined as time from randomization to disease progression or death.
Measured: 4 months

Secondary outcomes (9)

Objective Response Rate (ORR)
ORR will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Measured: The objective response is the best objective response observed from the start of treatment to progression.
Overall Survival (OS)
OS is defined as time from randomization to death due to any cause.
Measured: 3 years after last chemotherapy in study
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).
Measured: First progression
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.
Measured: 4 months
Dietary supplementation compliance
Compliance will be assessed through patient's diary.
Measured: 4 months
Quality Of Life (QOL)
QOL will be assessed by QLQ-C30 and BR23 questionnaires.
Measured: At C1, after 4 months of chemotherapy, and at the end of chemotherapy.
Pain evaluation
Pain will be assessed by a Visual Analog Scale (VAS) and analgesic consumption.
Measured: 4 months
DHA plasma level
Plasma phospholipids DHA incorporation will be measured with a blood sample.
Measured: Before dietary supplementation (at C1), and after 4 months of dietary supplementation.
Neuropathy evaluation
Neuropathy will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2014

First posted8 Mar 2012 (estimated)
Study startFeb 2012
Primary completionJun 2014
Study completionJun 2014

Why it stopped: Judicial liquidation of the society providing dietary supplementation.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01548534
Sponsor's protocol ID: PHRN11-PB
Other IDs: 2011-A01029-32
Acronym: DHALYA
Status last verified: Jul 2015
First submitted: 27 Feb 2012
Last updated: 29 Jul 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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