Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)

Study Overview
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Brief Summary
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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'.

Official Title
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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

Conditions
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Cancer, Peripheral Neuropathy

Intervention / Treatment
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* Drug: Ethosuximide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsule | Drug: Placebo<br>* Capsule<br>|
| Experimental: Drug<br> | Drug: Ethosuximide<br>* Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale. |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult cancer patients with chemotherapy-induced painful peripheral neuropathy