Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer
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.
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: alpha-lipoic acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial|
- Severity of neuropathy [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]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
- Group Differences in Change scores [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks
- Number of courses received [ Time Frame: Up 48 weeks ] [ Designated as safety issue: No ]
- Optimal tumor response [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I: Alpha-Lipoic Acid
Oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity.
Drug: alpha-lipoic acid
Oral two 300 mg ALA sustained release tablets initiated 4 days after last dose of platinum and discontinued 2 days before next scheduled platinum dose, continued for 24 weeks.
Placebo Comparator: Arm II: Placebo
Oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity.
Given orally two similar color and sized placebo control tablets three times a day continued for 24 weeks.
- 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.
- 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.
- 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.
|United States, Arkansas|
|Hembree Mercy Cancer Center at St. Edward Mercy Medical Center|
|Fort Smith, Arkansas, United States, 72913|
|United States, Indiana|
|Horizon Oncology Center|
|Lafayette, Indiana, United States, 47905|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Louisiana|
|Cabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital|
|Alexandria, Louisiana, United States, 71301|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|St. Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|Cancer Research for the Ozarks|
|Springfield, Missouri, United States, 65804|
|United States, Oregon|
|CCOP - Columbia River Oncology Program|
|Portland, Oregon, United States, 97225|
|United States, Pennsylvania|
|CCOP - Main Line Health|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|United States, Texas|
|University of Texas M.D. Anderson CCOP Research Base|
|Houston, Texas, United States, 77030-4009|
|CCOP - Scott and White Hospital|
|Temple, Texas, United States, 76508|
|United States, Wisconsin|
|Marshfield Clinic - Marshfield Center|
|Marshfield, Wisconsin, United States, 54449|
|Principal Investigator:||Ying Guo, MD, MS||M.D. Anderson Cancer Center|