Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
Status and phase
Conditions
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Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
OBJECTIVES:
Primary
Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin.
Secondary
Determine if this drug improves the oxidative state, as measured by a malondialdehyde measurement of oxidative stress, thereby protecting the patient against ototoxic-induced hearing loss.
OUTLINE: This is a placebo-controlled, double-blind, randomized, multicenter study. Patients are stratified by cancer stage and institution. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral alpha-lipoic acid supplement once a day beginning 1 week before the start of cisplatin treatment and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.
Arm II: Patients receive oral placebo supplement once a day beginning 1 week before the start of cisplatin and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.
Hearing and ototoxicity are assessed at baseline, on each day of chemotherapy, and at 1 and 3 months post chemotherapy.
Blood samples are collected periodically to measure malondialdehyde and alpha-lipoic acid levels.
After completion of treatment with cisplatin, patients are followed for 3 months.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
39 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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