NCT00477607

Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin

Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin. PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin.

Detailed description

OBJECTIVES: Primary Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin. Secondary Determine if this drug improves the oxidative state, as measured by a malondialdehyde measurement of oxidative stress, thereby protecting the patient against ototoxic-induced hearing loss. OUTLINE: This is a placebo-controlled, double-blind, randomized, multicenter study. Patients are stratified by cancer stage and institution. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral alpha-lipoic acid supplement once a day beginning 1 week before the start of cisplatin treatment and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment. Arm II: Patients receive oral placebo supplement once a day beginning 1 week before the start of cisplatin and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment. Hearing and ototoxicity are assessed at baseline, on each day of chemotherapy, and at 1 and 3 months post chemotherapy. Blood samples are collected periodically to measure malondialdehyde and alpha-lipoic acid levels. After completion of treatment with cisplatin, patients are followed for 3 months.

Conditions

• Ototoxicity
• Unspecified Adult Solid Tumor

Interventions

Type	Name	Description
DRUG	alpha-lipoic acid	Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
BEHAVIORAL	Audiology	otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
BIOLOGICAL	laboratory biomarker analysis	Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
DRUG	Placebo	Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-03-01
• Completion: 2011-06-01
• First posted: 2007-05-24
• Last updated: 2014-03-07
• Results posted: 2014-01-29

Locations

2 sites across 1 country: United States