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
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
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.
OBJECTIVES Primary
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.
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>
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:>
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>
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
La Porte, Indiana 46350, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Portland, Oregon 97213-2967, United States
Portland, Oregon 97227, United States
Wilkes-Barre, Pennsylvania 18711, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States