search
Back to results

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

Primary Purpose

Cancer, Peripheral Neuropathy

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Ethosuximide
Placebo
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Adult cancer patients with chemotherapy-induced painful peripheral neuropathy

Eligibility Criteria

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

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.

Sites / Locations

  • Royal Marsden NHS Foundation Trust
  • The Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Drug

Arm Description

Placebo capsule

Outcomes

Primary Outcome Measures

Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2011
Last Updated
May 25, 2016
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Imperial College London
search

1. Study Identification

Unique Protocol Identification Number
NCT01278004
Brief Title
Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)
Acronym
CINE-E
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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'.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Peripheral Neuropathy
Keywords
Adult cancer patients with chemotherapy-induced painful peripheral neuropathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Arm Title
Drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ethosuximide
Intervention Description
Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule
Primary Outcome Measure Information:
Title
Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs