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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Collaborator: Oregon Health and Science University
• Treatments: Cisplatin; Thioctic Acid

Criteria

Inclusion Criteria:

• Diagnosis of cancer

• Receiving therapeutic treatment with cisplatin

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• Cognitively and physically able to participate in the study

• Must be able to provide reliable behavioral threshold responses (patient must meet intra-session reliability criterion of +/- 5 dB)

• At least 6 months since prior treatment with cisplatin or other ototoxic medications (e.g., aminoglycoside antibiotics)

• At least 6 months since prior and no concurrent radiotherapy for head and neck tumors

• Concurrent radiotherapy targeted below the neck allowed

• More than 1 month since prior alpha-lipoic acid supplements

Exclusion Criteria:

• No aggressive behavior as indicated in electronic chart notes

• No documented dementia

• No Alzheimer's disease

• No severe psychosocial disorder

• No active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance, or notes in patient chart

• No renal disease

• No Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart

• Not receiving treatment for diabetes mellitus

• No concurrent vincristine or vinblastine

• No other concurrent investigational therapy

• No other concurrent antioxidants or vitamin E > 100 IU per day