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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00911-40 |
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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
| Ligue contre le cancer - Auvergne | UNKNOWN |
Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles.
To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals.
So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.
This is a prospective, single-center, controlled and interventional study with two parallel groups randomized in single-blind.
After obtaining informed consent, all included patients will be randomized, either:
Randomization will be performed by considering stratification on the tumor presence or not, because it is one of the polyamines source (Linsalata and Russo, 2008) and could influence the results in the study.
In addition, patient compliance will be collected in the case report form all along the study, and included in the statistical analysis of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyamines depleted diet | Experimental | • in the group with a polyamines depleted diet : 2-4 cans per day of Polydol® (oral alimentation without polyamines), associated to predefined menus low in polyamines, according to the chemotherapy cycle and for 107 days |
|
| normal polyamines containing diet | Other | • in the control group with a normal polyamines containing diet: 1 can per day of Polydol® associated with predefined menus with normal average in polyamines and for 107 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cold pain thresholds | day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Cold pain thresholds | day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 | |
| Heat pain thresholds | day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 | |
| DN4 (Douleur Neuropathique en 4 Questions) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis PEZET | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25833669 | Derived | Balayssac D, Ferrier J, Pereira B, Gillet B, Petorin C, Vein J, Libert F, Eschalier A, Pezet D. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial. BMJ Open. 2015 Apr 1;5(4):e007479. doi: 10.1136/bmjopen-2014-007479. |
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| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D006930 | Hyperalgesia |
| D010292 | Paresthesia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D020886 | Somatosensory Disorders |
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| ID | Term |
|---|---|
| D011073 | Polyamines |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 |
| HADS (Hospital Anxiety and Depression Scale) score | day -7, 0, 14, 28, 42, 98, 154 |
| Adverse drug reactions (CTCAE (Common Terminology Criteria for Adverse Events)) | day 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 |
| Cancer response | day 154 |
| Oxaliplatin dose intensity | day 154 |
| Erythrocyte polyamine levels | day -7, 0, 14, 28, 42, 70, 98 |
| NPSI ( Neuropathic Pain Symptom Inventory)scores | day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 |
| QLQ-C30 (Quality of Life questionnaire C30)scores | day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |