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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ototoxicity, Unspecified Adult Solid Tumor

In brief

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.

Key facts

Study ID

NCT00477607

Run by

US Department of Veterans Affairs

People needed

39

Starts

2007-10-01

Expected to finish

2011-06-01

Last updated by the study team

2014-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Portland — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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