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Trial NCT00516503

Resource URI: http://static.linkedct.org/resource/trials/NCT00516503
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/34503>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/35069>
linkedct:brief_title Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
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linkedct:criteria 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, amitriptyline hydrochloride, and/or ketamine - No diagnosis of any New York Heart Association class I-IV congestive heart failure - No diagnosis of coronary artery disease including, but not limited to, myocardial infarction, within the past 5 years - No other medical condition that, in the opinion of the treating physician or allied health professional, would make this clinical trial unreasonably hazardous for the patient - No skin abnormalities at the intended application sites (hands and feet) of study gel (i.e., skin breakdown) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 30 days since prior anticonvulsants, tricyclic antidepressants, monoamine oxidase inhibitor, or other neuropathic pain medication (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine) - Patients treated with any of these agents for peripheral neuropathy for  1 week during the past 30 days are eligible provided they are no longer taking the agent - More than 5 years since prior percutaneous transluminal coronary angioplasty or coronary artery bypass graft - Prior heart valve replacement surgery allowed provided patient has fully recovered from the surgery - No concurrent use of study agents other than as specified in the trial
linkedct:description OBJECTIVES: Primary - Compare the effectiveness of baclofen-amitriptyline hydrochloride-ketamine (BAK) gel versus placebo, in terms of improving sensory neuropathy, in cancer patients with chemotherapy-induced peripheral neuropathy. Secondary - Compare motor and autonomic symptoms and functioning, mood states, pain, and peripheral neuropathy in these patients. - Assess the adverse event profile of topical BAK gel. - Explore whether topical BAK gel is absorbed systemically. OUTLINE: Patients are stratified according to neurotoxic chemotherapy (active vs non-active), current use of opioids or oral pain medications (yes vs no), pain rating (4-7 vs 8-10), and prior ineffective pharmacologic treatment for peripheral neuropathy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. - Arm II: Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Some patients in both arms may choose to continue on the active gel or, if on placebo, begin the active gel for an additional 8 weeks off study. Patients complete health, pain, mood, and quality of life questionnaires at baseline and periodically during study. Patients also record adverse symptoms weekly in a Symptom Experience Diary.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 148 (xsd:int)
linkedct:firstreceived_date August 14, 2007
linkedct:id NCT00516503
linkedct:intervention <http://static.linkedct.org/resource/intervention/101983>
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rdfs:label Trial NCT00516503
linkedct:lastchanged_date November 21, 2009
linkedct:lead_sponsor_agency North Central Cancer Treatment Group
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linkedct:nct_id NCT00516503
linkedct:number_of_arms 2 (xsd:int)
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linkedct:official_title The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine (BAK) in a PLO Gel vs. Placebo for the Treatment of Chemotherapy Induced Peripheral Neuropathy: A Phase III Randomized Double-Blind Placebo Controlled Study
linkedct:org_study_id CDR0000560732
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/13361>
linkedct:overall_status Suspended
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00516503>
linkedct:phase Phase 3
linkedct:primary_completion_date June 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/25031>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/124>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/1980>
linkedct:secondary_id NCCTG-N06CA
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/11718>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/47209>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/67685>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/68111>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/72734>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/79115>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/83641>
linkedct:source National Cancer Institute (NCI)
linkedct:start_date February 2008
linkedct:study_design Supportive Care, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2009