CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
alpha-lipoic acid +3 moredrug
Likely dose
alpha-lipoic acid 1200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00477607
NCT00477607Phase 3Completed

Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid

US Department of Veterans Affairs·interventional·Posted May 24, 2007·Updated Mar 7, 2014

In Brief

A Phase 3 clinical trial evaluating alpha-lipoic acid, Audiology, and 2 other interventions for Ototoxicity and Unspecified Adult Solid Tumor. Completed, enrolled 39 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2007
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.1 years ago

Interventions

alpha-lipoic aciddrug

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.

Audiologybehavioral

otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

laboratory biomarker analysisbiological

Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

Placebodrug

Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.