NCT01775449

Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * 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 * 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. 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.

Conditions

• Neuropathy
• Digestive Cancer System

Interventions

Type	Name	Description
BEHAVIORAL	Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines

Timeline

• Start date: 2013-02-02
• Primary completion: 2015-01-06
• Completion: 2015-01-06
• First posted: 2013-01-25
• Last updated: 2017-07-11

Locations

1 site across 1 country: France