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Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet (NEUROXAPOL)

Primary Purpose

Neuropathy, Digestive Cancer System

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neuropathy focused on measuring Anticancer drug;, Oxaliplatin;, Digestive cancer system, Acute oxaliplatin-induced hypersensitivity, Hyperalgesia;, Allodynia;, Dysesthesia, Polyamines depleted diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

polyamines depleted diet

normal polyamines containing diet

Arm 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

• 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.

Outcomes

Primary Outcome Measures

Cold pain thresholds

Secondary Outcome Measures

Cold pain thresholds
Heat pain thresholds
DN4 (Douleur Neuropathique en 4 Questions) scores
HADS (Hospital Anxiety and Depression Scale) score
Adverse drug reactions (CTCAE (Common Terminology Criteria for Adverse Events))
Cancer response
Oxaliplatin dose intensity
Erythrocyte polyamine levels
NPSI ( Neuropathic Pain Symptom Inventory)scores
QLQ-C30 (Quality of Life questionnaire C30)scores

Full Information

First Posted
January 7, 2013
Last Updated
July 10, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Apicil, Ligue contre le cancer - Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT01775449
Brief Title
Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
Acronym
NEUROXAPOL
Official Title
Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2, 2013 (Actual)
Primary Completion Date
January 6, 2015 (Actual)
Study Completion Date
January 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Apicil, Ligue contre le cancer - Auvergne

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Digestive Cancer System
Keywords
Anticancer drug;, Oxaliplatin;, Digestive cancer system, Acute oxaliplatin-induced hypersensitivity, Hyperalgesia;, Allodynia;, Dysesthesia, Polyamines depleted diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polyamines depleted diet
Arm Type
Experimental
Arm 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
Arm Title
normal polyamines containing diet
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
Primary Outcome Measure Information:
Title
Cold pain thresholds
Time Frame
day 42
Secondary Outcome Measure Information:
Title
Cold pain thresholds
Time Frame
day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Title
Heat pain thresholds
Time Frame
day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Title
DN4 (Douleur Neuropathique en 4 Questions) scores
Time Frame
day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Title
HADS (Hospital Anxiety and Depression Scale) score
Time Frame
day -7, 0, 14, 28, 42, 98, 154
Title
Adverse drug reactions (CTCAE (Common Terminology Criteria for Adverse Events))
Time Frame
day 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Title
Cancer response
Time Frame
day 154
Title
Oxaliplatin dose intensity
Time Frame
day 154
Title
Erythrocyte polyamine levels
Time Frame
day -7, 0, 14, 28, 42, 70, 98
Title
NPSI ( Neuropathic Pain Symptom Inventory)scores
Time Frame
day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154
Title
QLQ-C30 (Quality of Life questionnaire C30)scores
Time Frame
day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis PEZET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25833669
Citation
Balayssac 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.
Results Reference
derived

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Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet

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