Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing

Status Completed

Clinical Trial 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.

Clinical Trial Description

OBJECTIVES:

Primary

Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin.

Secondary

Determine if this drug improves the oxidative state, as measured by a malondialdehyde measurement of oxidative stress, thereby protecting the patient against ototoxic-induced hearing loss.

OUTLINE: This is a placebo-controlled, double-blind, randomized, multicenter study. Patients are stratified by cancer stage and institution. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral alpha-lipoic acid supplement once a day beginning 1 week before the start of cisplatin treatment and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.

Arm II: Patients receive oral placebo supplement once a day beginning 1 week before the start of cisplatin and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.

Hearing and ototoxicity are assessed at baseline, on each day of chemotherapy, and at 1 and 3 months post chemotherapy.

Blood samples are collected periodically to measure malondialdehyde and alpha-lipoic acid levels.

After completion of treatment with cisplatin, patients are followed for 3 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00477607
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	October 2007
Completion date	June 2011

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT01624324` - Aminoglycoside Plasma Level Measurement in Neonates With Infection	N/A
Completed	`NCT00458887` - Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin	N/A
Recruiting	`NCT03480971` - Treatment of Radiation and Cisplatin Induced Toxicities With Tempol	Phase 2
Completed	`NCT00716976` - Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy	Phase 3
Completed	`NCT01139281` - The Protective Effect of Ginkgo Biloba Extract on Cisplatin-induced Ototoxicity in Humans	Phase 2
Enrolling by invitation	`NCT02819856` - SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity	Phase 2
Terminated	`NCT04226456` - Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity	Phase 4
Recruiting	`NCT05641441` - Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Completed	`NCT01263262` - A Comparison of Infection Rates Between Two Surgical Sites	N/A
Not yet recruiting	`NCT01285674` - Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.	N/A
Not yet recruiting	`NCT01451853` - SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss	Phase 2
Completed	`NCT04262336` - Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment	Phase 1
Not yet recruiting	`NCT00578760` - Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?	N/A
Completed	`NCT00652132` - Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, II, or III Childhood Liver Cancer	Phase 3
Withdrawn	`NCT02382068` - Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin	N/A
Recruiting	`NCT01216800` - Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors	Phase 3
Completed	`NCT01848457` - Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy	Phase 2
Active, not recruiting	`NCT00683319` - Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms