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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

March 31, 2011

Study Completion Date

June 30, 2011

Conditions
OtotoxicityUnspecified Adult Solid Tumor
Interventions
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.

Trial Locations (2)

97201

VA Medical Center, Portland, Portland

97239

Oregon Health & Science University, Portland

All Listed Sponsors
collaborator

Oregon Health and Science University

OTHER

lead

US Department of Veterans Affairs

FED

NCT00477607 - Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin | Biotech Hunter | Biotech Hunter