Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
18 Years
70 Years
Both
Neuropathy, Digestive Cancer System
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Cold pain thresholds
Outcome Time Frame:
day 42
Safety Issue:
Yes
Principal Investigator
Denis PEZET
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Clermont-Ferrand
Authority:
France: Ministry of Health
Study ID:
CHU-0137
NCT ID:
NCT01775449
Start Date:
January 2013
Completion Date:
January 2015
Related Keywords:
- Neuropathy
- Digestive Cancer System
- Anticancer drug;
- Oxaliplatin;
- Digestive cancer system
- Acute oxaliplatin-induced hypersensitivity
- Hyperalgesia;
- Allodynia;
- Dysesthesia
- Polyamines depleted diet
- Neuralgia
- Gastrointestinal Neoplasms
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