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.
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
- Are there results?
- None posted in the registry
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.
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
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
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 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 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.
- 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.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Cancerologie de l'Ouest
- Responsible party
- Sponsor
- Investigators
- Philippe Bougnoux, MD, PhD, Principal investigator, University Hospital, Tours
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01548534
- Acronym / sponsor ID
- DHALYA / PHRN11-PB
- Conditions
- Metastatic Breast Cancer, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor, HER-2 Negative Tumor
- Keywords
- Metastatic Breast Cancer, First-Line chemotherapy, Taxane or Anthracycline, DHA, PUFA, Dietary supplementation, First-Line Taxane or Anthracycline based chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Judicial liquidation of the society providing dietary supplementation.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Institut Cancerologie de l'Ouest
- Study start
- Feb 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA-free arm | Placebo comparator | Dietary Supplement: Dietary supplementation with vegetable oilDietary supplementation with vegetable oil. |
| DHA arm | Experimental | Dietary Supplement: Dietary supplementation with fish oil.Dietary supplementation with fish oil. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | DHA arm |
| Dietary supplementation with vegetable oilPatients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA. | Dietary supplement | DHA-free arm |
Primary outcome
Progression Free Survival (PFS)
Time frame: 4 months
PFS is defined as time from randomization to disease progression or death.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: The objective response is the best objective response observed from the start of treatment to progression.
Overall Survival (OS)
Time frame: 3 years after last chemotherapy in study
Time To Progression (TTP)
Time frame: First progression
Safety ans tolerance of dietary supplementation/chemotherapy association
Time frame: 4 months
Dietary supplementation compliance
Time frame: 4 months
Quality Of Life (QOL)
Time frame: At C1, after 4 months of chemotherapy, and at the end of chemotherapy.
Pain evaluation
Time frame: 4 months
DHA plasma level
Time frame: Before dietary supplementation (at C1), and after 4 months of dietary supplementation.
Neuropathy evaluation
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Judicial liquidation of the society providing dietary supplementation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Bougnoux, MD, PhD principal investigator
University Hospital, Tours
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Judicial liquidation of the society providing dietary supplementation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.