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Status:

COMPLETED

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

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Neurotoxicity

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

Phase:

PHASE3

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-lip...

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 oxaliplat...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for cancer
  • No established clinical neuropathy
  • No clinically evident CNS metastases, including leptomeningeal metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • Not specified
  • Performance status
  • Not specified
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Bilirubin \< 2 mg/dL
  • Renal
  • Creatinine \< 2 mg/dL OR
  • Creatinine clearance \> 45 mL/min
  • Other
  • 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)
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • 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
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2014

    Estimated Enrollment :

    244 Patients enrolled

    Trial Details

    Trial ID

    NCT00112996

    Start Date

    January 1 2007

    End Date

    April 1 2014

    Last Update

    April 8 2014

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, United States, 72913

    2

    Horizon Oncology Center

    Lafayette, Indiana, United States, 47905

    3

    CCOP - Wichita

    Wichita, Kansas, United States, 67214-3882

    4

    Cabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital

    Alexandria, Louisiana, United States, 71301