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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01029-32 | Other Identifier | French Health Products Safety Agency |
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Judicial liquidation of the society providing dietary supplementation.
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| Name | Class |
|---|---|
| Institut Cancerologie de l'Ouest | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA-free arm | Placebo Comparator | Dietary supplementation with vegetable oil. |
|
| DHA arm | Experimental | Dietary supplementation with fish oil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as time from randomization to disease progression or death. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Bougnoux, MD, PhD | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest (ICO) | Angers | 49933 | France | |||
| Centre Hospitalier Jacques Coeur |
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| Dietary supplementation with vegetable oil | Dietary Supplement | Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA. |
|
OS is defined as time from randomization to death due to any cause. |
| 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). | 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. | 4 months |
| Dietary supplementation compliance | Compliance will be assessed through patient's diary. | 4 months |
| 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. |
| Pain evaluation | Pain will be assessed by a Visual Analog Scale (VAS) and analgesic consumption. | 4 months |
| 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. |
| Neuropathy evaluation | Neuropathy will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | 4 months |
| Bourges |
| 18016 |
| France |
| CHU Morvan | Brest | 29609 | France |
| Centre François Baclesse | Caen | 14076 | France |
| Centre Hospitalier | Cholet | 49325 | France |
| Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon | 85925 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Hospitalier Bretagne sud | Lorient | 56100 | France |
| Clinique Guillaume de Varye | Saint-Doulchard | 18230 | France |
| Centre Hospitalier Privé | Saint-Grégoire | 35768 | France |
| CHU Bretonneau | Tours | 37044 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005395 | Fish Oils |
| D010938 | Plant Oils |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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