Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer
- Conditions
- NeurotoxicityUnspecified Childhood Solid Tumor, Protocol SpecificUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: placebo
- Registration Number
- NCT00112996
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as alpha-lipoic acid, may protect normal cells from the side effects of chemotherapy. Alpha-lipoic acid may also prevent damage to nerves that carry information to and from the brain and spinal cord to the rest of the body. It is not known whether alpha-lipoic acid is more effective than placebo in preventing peripheral neuropathy.
PURPOSE: This randomized phase III trial is studying alpha-lipoic acid to see how well it works compared to placebo in preventing peripheral neuropathy in patients receiving chemotherapy for cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare whether treatment with alpha-lipoic acid vs placebo decreases the severity and frequency of peripheral neuropathy in cancer patients receiving a cisplatin- or oxaliplatin-containing chemotherapy regimen.
* Compare the protective effect duration of these drugs in these patients.
Secondary
* Determine large sensory fiber integrity associated with platinum-induced peripheral neuropathy, as measured by three timed functional tests comprising fastening 6-buttons, walking 50 feet, and placing coins in a cup, in patients treated with these drugs.
* Compare the number of chemotherapy courses and doses received by patients treated with these drugs.
Tertiary
* Compare the optimal tumor response (disease progression, stable disease, partial response, or complete response) to chemotherapy in patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior platinum-containing treatment (yes vs no). Patients who received prior treatment are further stratified according to prior cumulative platinum exposure (cisplatin \< 200 mg/m\^2 or oxaliplatin \< 750 mg/m\^2 vs cisplatin 200-399 mg/m\^2 or oxaliplatin 750-999 mg/m\^2 vs cisplatin \>400 mg/m\^2 or oxaliplatin \> 1,000 mg/m\^2). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral alpha-lipoic acid\* three times daily for at least 24 weeks in the absence of unacceptable toxicity.
* Arm II: Patients receive oral placebo\* three times daily for at least 24 weeks in the absence of unacceptable toxicity.
NOTE: \*In both arms, patients begin taking study drug 4 days after completion of each chemotherapy treatment and continue taking study drug until 2 days before their next scheduled chemotherapy treatment.
Patients' symptoms of peripheral neuropathy, pain, and functional tests are assessed at baseline and then at weeks 6-8, 12, 24, 36, and 48.
PROJECTED ACCRUAL: A total of 244 patients (122 per treatment arm) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I: Alpha-Lipoic Acid alpha-lipoic acid Oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity. Arm II: Placebo placebo Oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Severity of neuropathy Up to 48 weeks Severity of neuropathy as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire total score at baseline and at 6-8, 12, 24, 36, and 48 weeks
- Secondary Outcome Measures
Name Time Method Number of courses received Up 48 weeks Optimal tumor response Up to 48 weeks Group Differences in Change scores Up to 48 weeks Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks
Trial Locations
- Locations (13)
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Cabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital
🇺🇸Alexandria, Louisiana, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Horizon Oncology Center
🇺🇸Lafayette, Indiana, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸St. Louis Park, Minnesota, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
University of Texas M.D. Anderson CCOP Research Base
🇺🇸Houston, Texas, United States