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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

Page last updated: February 07, 2013

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