Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Che… (NCT00516503) | Clinical Trial Compass
CompletedPhase 3
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
United States208 participantsStarted 2008-02
Plain-language summary
RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy .
PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:\>
* Diagnosis of cancer\>
* Received or currently receiving neurotoxic chemotherapy including, but not limited to, taxanes (e.g., paclitaxel or docetaxel); platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin); vinca alkaloids (e.g., vincristine or vinblastine); or other neurotoxic chemotherapy agents (e.g., bortezomib, lenalidomide, or thalidomide)\>
* Must have pain or symptoms of peripheral neuropathy attributable to chemotherapy for ≥ 1 month\>
* Neuropathy is limited to either hands and/or feet where gel can be applied\>
* Neuropathic pain score of ≥ 4 out of 10 on the numbness/tingling/pain numeric analogue scale\>
* No pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (e.g., diabetes, alcohol, toxin, heredity)\> PATIENT CHARACTERISTICS:\>
* ECOG performance status 0-2\>
* Life expectancy ≥ 4 months\>
* Creatinine ≤ 1.5 times upper limit of normal\>
* Not pregnant or nursing\>
* No ability to bear children defined by 1 of the criteria:\>
* Menopausal (12 months and no menstrual period if natural menopause)\>
* Underwent a hysterectomy and/or oophorectomy\>
* Permanent surgical sterilization (tubal ligation)\>
* Fertile patients must use effective contraception\>
* Able to complete questionnaires independently or with assistance\>
* Able to sign informed consent and understand the nature of a placebo-controlled trial\>
* No history of an allergic reaction to baclofen, amitript…
What they're measuring
1
Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]