Overview

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