Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin (NCT00477607) | Clinical Trial Compass
CompletedPhase 2/3
Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
United States39 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Ototoxicity Measurement
Timeframe: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.