Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet

Neuropathy Clinical Trial

— NEUROXAPOL  

Official title:

Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775449
• Other study ID #: CHU-0137
• Secondary ID: 2011-A00911-40
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2013
• Last updated: July 10, 2017
• Start date: February 2, 2013
• Est. completion date: January 6, 2015

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 6, 2015
• Est. primary completion date: January 6, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive Cancer System
• Neuralgia
• Neuropathy

Intervention

Behavioral:
• Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Fondation Apicil, Ligue contre le cancer – Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold pain thresholds		day 42
Secondary	Cold pain thresholds		day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Secondary	Heat pain thresholds		day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Secondary	DN4 (Douleur Neuropathique en 4 Questions) scores		day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Secondary	HADS (Hospital Anxiety and Depression Scale) score		day -7, 0, 14, 28, 42, 98, 154
Secondary	Adverse drug reactions (CTCAE (Common Terminology Criteria for Adverse Events))		day 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Secondary	Cancer response		day 154
Secondary	Oxaliplatin dose intensity		day 154
Secondary	Erythrocyte polyamine levels		day -7, 0, 14, 28, 42, 70, 98
Secondary	NPSI ( Neuropathic Pain Symptom Inventory)scores		day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Secondary	QLQ-C30 (Quality of Life questionnaire C30)scores		day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154