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Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial

Phase 3
Not Enrolling
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial



- 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.

Inclusion Criteria


- Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for

- 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


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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Severity of neuropathy

Outcome Description:

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

Outcome Time Frame:

Up to 48 weeks

Safety Issue:


Principal Investigator

Ying Guo, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

December 2011

Related Keywords:

  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • neurotoxicity
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • Peripheral Nervous System Diseases
  • Neurotoxicity Syndromes
  • Neoplasms



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