Clinical trial · Interventional
Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
NCT01775449CI-TRIAL-00028561NEUROXAPOLcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive Cancer System | — | UNRESOLVED | — |
| Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- polyamines depleted diet
- description
- • 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
- interventionNames
- Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
- type
- OTHER
- label
- normal polyamines containing diet
- description
- • 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.
- interventionNames
- Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * \- Patients affected by gastrointestinal cancer, without cytotoxic neurotoxic chemotherapy, had to receive FOLFOX 4 chemotherapy (folinic acid + 5-FU + oxaliplatin) in the adjuvant, neoadjuvant or palliative situation with an expected period of 8 cures of treatment or 4 months. * Patients having given their written, free and informed consent * Patient's members of a social security scheme * Patients not having participated in another clinical trial within 15 days before its baseline (possibility of participating and / or participate in an observational trial) * Effective contraception for patients, male or female, in childbearing age. * Neutrophils \> 2.109/L and/or platelet \> 100.109/L before the first treatment cycle Exclusion Criteria: * \- Patient which cannot receive FOLFOX 4 whatever the reason * Patients \< 18 years old and \> 70 years old * Malnourished patient (French National Authority for Health, 2003) * Patients with all or part of an upper limb amputation * Diabetic patient * Patients with neuropathy * Oral nutrition impossible * Painful procedures scheduled after the baseline (e.g. surgical excision) * Neurological disorders (e.g. parkinsonism, stroke ...) * Alcohol consumption upper 3 alcohol units (30 g) for men and upper 2 alcohol units (20 g) for women * Patients having already received cytotoxic neurotoxic chemotherapy (taxanes, platinum salts or vinca alkaloids) * Patients treated for another cancer within 5 years except basal cell skin carcinoma or in situ cervical cancer * Any unbalanced progressive disease (hepatic failure, renal insufficiency (creatinine clearance \<30 mL / min), respiratory failure, congestive heart failure, myocardial infarction within the past 6 months ...) * Patients requiring Ca2 + or Mg2 + perfusions * Hypersensitivity or allergy known about one of study product's component * Pregnant woman or breastfeeding woman * Legal disability (person deprived of liberty or under guardianship) * Patients for psychological, social, family or geographical reasons can not be monitored regularly and / or be compliant with the requirements of the study * Patients already included in another clinical trial
References
Publications (1)
- DERIVEDBalayssac 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. PMID 25833669