Phase 3 N=39 Randomized Triple-blind Supportive Care

Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin

Ototoxicity · Unspecified Adult Solid Tumor

Bottom Line

View on ClinicalTrials.gov: NCT00477607 ↗

Enrolled (actual)

Serious AEs

28.2%

Results posted

Jan 2014

Primary outcome: Primary: Ototoxicity Measurement — 7; 7 participants — p=0.89

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: alpha-lipoic acid (Drug); Audiology (Behavioral); laboratory biomarker analysis (Biological); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Mar 2011

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

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.

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

View full record on ClinicalTrials.gov →

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.