Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00477607 · ClinicalTrials.gov registry record · Phase 2
Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
A Phase 2 study of Ototoxicity and Unspecified Adult Solid Tumor, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 2
- Study locations
NCT00477607: Completed Phase 2 study of Ototoxicity and Unspecified Adult Solid Tumor, sponsored by US Department of Veterans Affairs.
NCT00477607 is a Phase 2 study of Ototoxicity and Unspecified Adult Solid Tumor that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 39 participants, below the 148-participant average among 3 other Ototoxicity trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00477607, a Phase 2 study of Ototoxicity and Unspecified Adult Solid Tumor, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement. ASHA criteria are defined as * 20 decibel (dB) increase at any test frequency, * 10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG alpha-lipoic acid
- BEHAVIORAL Audiology
- BIOLOGICAL laboratory biomarker analysis
Study Locations (2)
Oregon
- VA Medical Center, Portland - Portland
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT00477607 record still lists
NCT00477607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 148-participant average among 3 other Ototoxicity trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Ototoxicity appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00477607 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT00477607 about?
NCT00477607 is a clinical study titled "Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin". 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.
What is the current status of trial NCT00477607?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2007-10. Estimated completion is 2011-06.
What conditions does trial NCT00477607 study?
This clinical trial studies the following conditions: Ototoxicity, Unspecified Adult Solid Tumor.
What interventions are being tested in trial NCT00477607?
The interventions under investigation include: Placebo (DRUG), alpha-lipoic acid (DRUG), Audiology (BEHAVIORAL), laboratory biomarker analysis (BIOLOGICAL).
Who is sponsoring clinical trial NCT00477607?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00477607 being conducted?
This trial has 2 study locations across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ototoxicity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
RECRUITING · Phase 2
-
Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment
COMPLETED · Phase 1
-
Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03465592 · 39 participants · Phase 1
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
- NCT03961776 · 39 participants
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- NCT04050280 · 39 participants · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
- NCT04190862 · 39 participants · Phase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia