Clinical trial · Interventional
Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid
NCT00477607CI-TRIAL-00013964completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ototoxicity | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alpha-lipoic acid | Drug | — | UNRESOLVED |
| Audiology | Behavioral | — | UNRESOLVED |
| laboratory biomarker analysis | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Receiving alpha-lipoic acid during cisplatin treatment.
- interventionNames
- Drug: alpha-lipoic acid
- Behavioral: Audiology
- Biological: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Receiving placebo during cisplatin treatment
- interventionNames
- Behavioral: Audiology
- Biological: laboratory biomarker analysis
- Drug: Placebo
Primary outcomes (1)
- measure
- Ototoxicity Measurement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.