Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	Not specified	NCI	MDA-CCC-0327 2004-0728, MDA-2004-0728, MDACCC 03-27, NCT00112996

Special Category: NCI Web site featured trial

Objectives

Primary

1. 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.
2. Compare the protective effect duration of these drugs in these patients.

Secondary

1. 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.
2. Compare the number of chemotherapy courses and doses received by patients treated with these drugs.

Tertiary

1. Compare the optimal tumor response (disease progression, stable disease, partial response, or complete response) to chemotherapy in patients treated with these drugs.

Entry Criteria

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

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., annodyne [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

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 CNS disease (e.g., dementia or encephalopathy)

Expected Enrollment

A total of 244 patients (122 per treatment arm) will be accrued for this study within 2 years.

Outcomes

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 from baseline at 6-8, 12, 24, 36, and 48 weeks
Number of courses received
Optimal tumor response

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/m² or oxaliplatin < 750 mg/m² vs cisplatin 200-399 mg/m² or oxaliplatin 750-999 mg/m² vs cisplatin >400 mg/m² or oxaliplatin > 1,000 mg/m²). 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.

Trial Contact Information

Trial Lead Organizations

University of Texas M.D. Anderson CCOP Research Base

Ying Guo, MD, MS, Principal investigator		Ph: 713-745-2327 Email: yguo@mdanderson.org

Related Information

Featured trial article

Registry Information
Official Title		Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy with Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial
Trial Start Date		2007-01-03
Trial Completion Date		2010-01-03 (estimated)
Registered in ClinicalTrials.gov		NCT00112996
Date Submitted to PDQ		2004-10-27
Information Last Verified		2009-11-13
NCI Grant/Contract Number		CA16672

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