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Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin - NCT00477607-97201(Clinical Trial 170791)



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City:  Portland
State:  
OR
Zip Code: 97201
Conditions: Ototoxicity - Unspecified Adult Solid Tumor
Purpose: 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.
Study summary: 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.
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
Study is available at: VA Medical Center, Portland
Portland, OR 97201
United States

Primary Contact:
Debra Wilmington, PhD
Email: debra.wilmington@va.gov
Phone: 503-220-8262

Secondary Contact:
Debra Wilmington, PhD
Email: debra.wilmington@va.gov
Phone: (503) 220-8262
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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