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Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00112996
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : April 8, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Drug: alpha-lipoic acid Other: placebo Phase 3

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2007
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
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.
Other: placebo
Given orally two similar color and sized placebo control tablets three times a day continued for 24 weeks.

Primary Outcome Measures :
  1. Severity of neuropathy [ Time Frame: 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 :
  1. Group Differences in Change scores [ Time Frame: Up to 48 weeks ]
    Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks

  2. Number of courses received [ Time Frame: Up 48 weeks ]
  3. Optimal tumor response [ Time Frame: Up to 48 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for cancer
  • No established clinical neuropathy
  • No clinically evident CNS metastases, including leptomeningeal metastases



  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin < 2 mg/dL


  • Creatinine < 2 mg/dL OR
  • Creatinine clearance > 45 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must have a normal state of arousal
  • No confusion or memory or concentration deficit
  • No history of diabetes mellitus requiring oral medication or insulin treatment
  • No chronic alcoholism
  • No other active central nervous system (CNS) disease (e.g., dementia or encephalopathy)


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No carboplatin, vincristine, vinblastine, paclitaxel, or docetaxel for 6 months prior, during, and 6 months after study treatment

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • Concurrent medications that can modify peripheral neuropathy (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are allowed provided there is no dose adjustment within 2 weeks before study entry and during study participation
  • No concurrent vitamin E (including multivitamins that contain vitamin E) ≥ 100 IU per day
  • No concurrent physical modality (e.g., anodyne [monochromatic near-infrared photoenergy, 890 nm], microcurrent, or transcutaneous electrical neural stimulation) for peripheral neuropathy related symptoms unless physical or occupational therapy for functional training

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00112996

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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
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Ying Guo, MD, MS M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00112996    
Obsolete Identifiers: NCT00705029
Other Study ID Numbers: CDR0000403155
2004-0728 ( Other Identifier: UT MD Anderson Cancer Center )
NCI-2009-00636 ( Registry Identifier: NCI CTRP )
3U10CA045809-15S1 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2005    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Keywords provided by M.D. Anderson Cancer Center:
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Chemically-Induced Disorders
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances