CIN-E Study

• Research type

  Research Study

• Full title

  A randomised double-blind placebo-controlled trial of the safety and efficacy of ethosuximide for the management of chemotherapy-induced painful peripheral neuropathy.

• Sponsor organisation

  Royal Marsden NHS Foundation Trust

• Eudract number

  2008-004499-38

• ISRCTN Number

  Not submitted

• Research summary

  Chemotherapy-induced neuropathy occurs in approximately 30% of patients receiving paclitaxel and carboplatin chemotherapy for the treatment of ovarian cancer. The neuropathy may be painful and persist for months or years after chemotherapy is stopped. Unfortunately from our current repertoire of analgesics there is no effective treatment that provides relief for this type of pain when compared to placebo.The CIN-E study is a drug trial which assesses ethosuximide as a new potential analgesic agent for chemotherapy-induced painful peripheral neuropathy. Ethosuximide has been safely used for the treatment of ??petit mal? epilepsy in children since the 1960s, and there is good evidence from animal studies that it may be effective for this type of pain. 44 patients who develop chemotherapy-induced painful peripheral neuropathy from first-line paclitaxel/carboplatin treatment for ovarian cancer will be recruited to the trial. Participants will be randomised to either ethosuximide or placebo, and the dose titrated according to response. Any change in pain score, quality of life and anxiety/depression will be assessed using questionnaires. The drug trial will be of six weeks duration, with the participants again followed up at 3 months post- chemotherapy.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/108

• Date of REC Opinion

  24 Dec 2008

• REC opinion

  Further Information Favourable Opinion