Phase 3
Completed N=39
Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
Ototoxicity · Unspecified Adult Solid Tumor
Source: ClinicalTrials.gov NCT00477607 ↗
Enrolled (actual)
39
Serious AEs
28.2%
Results posted
Jan 2014
Primary outcomePrimary: Ototoxicity Measurement — 7; 7 participants — p=0.89
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ototoxicity Measurement |
7; 7 | 0.89 |
| SECONDARY Malondialdehyde (MDA) Levels |
0.27; 0.47 | 0.63 |
| SECONDARY Total Amount of Prescribed Cisplatin Dose Administered |
239.7; 191.5 | 0.15 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00477607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.