Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Condition: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Peripheral Nervous System Diseases; Myelodysplastic Syndromes; Myeloproliferative Disorders; Lymphoproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases
Intervention: baclofen/amitriptyline/ketamine gel; placebo
Intervention description: Applied topically; Applied topically
Intervention MeSH terms: Ketamine; Amitriptyline; Baclofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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>