Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Cold pain thresholds
University Hospital, Clermont-Ferrand
France: Ministry of Health