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

NCT00477607 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2014-03-07

Study results available
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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.

Conditions

  • Ototoxicity
  • Unspecified 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.

Sponsors & Collaborators

Principal Investigators

  • Dawn L Martin · Portland VA Medical Center, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-03-31
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00477607 on ClinicalTrials.gov