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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
Fondation Apicil
Ligue contre le cancer – Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01775449
First received: January 7, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Neuropathy
Digestive Cancer System
Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Cold pain thresholds [ Time Frame: day 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cold pain thresholds [ Time Frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 ] [ Designated as safety issue: Yes ]
  • Heat pain thresholds [ Time Frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 ] [ Designated as safety issue: Yes ]
  • DN4 (Douleur Neuropathique en 4 Questions) scores [ Time Frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 ] [ Designated as safety issue: Yes ]
  • HADS (Hospital Anxiety and Depression Scale) score [ Time Frame: day -7, 0, 14, 28, 42, 98, 154 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Cancer response [ Time Frame: day 154 ] [ Designated as safety issue: Yes ]
  • Oxaliplatin dose intensity [ Time Frame: day 154 ] [ Designated as safety issue: Yes ]
  • Erythrocyte polyamine levels [ Time Frame: day -7, 0, 14, 28, 42, 70, 98 ] [ Designated as safety issue: Yes ]
  • NPSI ( Neuropathic Pain Symptom Inventory)scores [ Time Frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 ] [ Designated as safety issue: Yes ]
  • QLQ-C30 (Quality of Life questionnaire C30)scores [ Time Frame: day -7, 0, 2, 14, 16, 28, 30, 42, 70, 72, 98, 100, 154 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polyamines depleted diet
• 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
Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
normal polyamines containing diet
• 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.
Behavioral: Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775449

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-celrmontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fondation Apicil
Ligue contre le cancer – Auvergne
Investigators
Principal Investigator: Denis PEZET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01775449     History of Changes
Other Study ID Numbers: CHU-0137, 2011-A00911-40
Study First Received: January 7, 2013
Last Updated: February 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Anticancer drug;
Oxaliplatin;
Digestive cancer system
Acute oxaliplatin-induced hypersensitivity
Hyperalgesia;
Allodynia;
Dysesthesia
Polyamines depleted diet

Additional relevant MeSH terms:
Neuralgia
Gastrointestinal Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014