Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)
Information source: Royal Marsden NHS Foundation Trust
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Peripheral Neuropathy
Intervention: Ethosuximide (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Royal Marsden NHS Foundation Trust Overall contact:
Julia Riley, Phone: 0207 80802761
Summary
This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side
effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive
substance) to test whether any response is a true effect of the drug, and not a 'placebo
effect'.
Clinical Details
Official title: A Randomised Double-blind Placebo-controlled Trial of the Safety and Efficacy of Ethosuximide 250mg Capsules for the Management of Chemotherapy Induced Painful Peripheral Neuropathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age >/= 18
- Diagnosis of cancer
- Willing and able to give informed consent to the CIN-E study and complete study
questionnaires, this involves adequate understanding of written and spoken English
(translators will not be used)
- Chemotherapy-induced painful peripheral neuropathy as diagnosed by score of >12 on
the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) with a pain
intensity rating of >4, on a 11 point numeric rating scale (0= no pain, 10= worst
possible pain).
- Duration of chemotherapy-induced painful peripheral neuropathy >4 weeks. Participant
may either have completed chemotherapy, or be receiving ongoing chemotherapy.
- Able to attend research centre according to the required visit schedule.
- Diet allows bovine gelatine (present in both ethosuximide and placebo capsules)
- Women of child-bearing potential must be using a reliable form of contraception i. e.
oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or
abstinence.
Exclusion Criteria:
- Renal impairment (serum creatinine >1. 5x normal level)
- Deranged liver function (AST>3x normal level)
- Patients currently taking any anti-depressant medication, for example fluoxetine,
paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week.
- Patients currently taking any other anti-epileptic drug, including gabapentin, or
within the past week.
- Pregnancy
- Allergy to succinimides, ethosuximide, methsuximide, phensuximide. Pre-exisitng
painful peripheral neuropathy of any other cause.
Locations and Contacts
Julia Riley, Phone: 0207 80802761
The Royal Marsden NHS Foundation Trust, London SW3 6JJ, United Kingdom; Recruiting
Christina Oyebode, Email: christina.oyebode@rmh.nhs.uk
Royal Marsden NHS Foundation Trust, Sutton, Surrey SM2 5PT, United Kingdom; Recruiting
Melanie Waghorn, Research Nurse, Phone: 0208661, Ext: 1025
Julia Riley, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: December 7, 2011
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