| ID | Type | Description | Link |
|---|---|---|---|
| MDA-CCC-0327 | |||
| MDA-2004-0728 | |||
| 2004-0728 | Other Identifier | UT MD Anderson Cancer Center | |
| NCI-2009-00636 | Registry Identifier | NCI CTRP | |
| 3U10CA045809-15S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
Tertiary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Alpha-Lipoic Acid | Experimental | Oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity. |
|
| Arm II: Placebo | Placebo Comparator | Oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha-lipoic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of neuropathy | 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 | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Group Differences in Change scores | Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks | Up to 48 weeks |
| Number of courses received | Up 48 weeks |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Ying Guo, MD, MS | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Fort Smith | Arkansas | 72913 | United States | ||
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 1, 2020 | |
| Reset | Sep 21, 2020 |
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| placebo | Other | Given orally two similar color and sized placebo control tablets three times a day continued for 24 weeks. |
|
| Optimal tumor response | Up to 48 weeks |
| Horizon Oncology Center |
| Lafayette |
| Indiana |
| 47905 |
| United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Cabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital | Alexandria | Louisiana | 71301 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Cancer Research for the Ozarks | Springfield | Missouri | 65804 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| CCOP - Main Line Health | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| University of Texas M.D. Anderson CCOP Research Base | Houston | Texas | 77030-4009 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 1, 2020 | Sep 21, 2020 |
| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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