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

NCT ID: NCT00477607

Last Updated: 2014-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-06-30

Brief 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.

Detailed 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.

Conditions

Ototoxicity; Unspecified Adult Solid Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Receiving alpha-lipoic acid during cisplatin treatment.

Group Type: EXPERIMENTAL

alpha-lipoic acid

Intervention Type: DRUG

Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.

Audiology

Intervention Type: BEHAVIORAL

otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

laboratory biomarker analysis

Intervention Type: BIOLOGICAL

Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

Arm 2

Receiving placebo during cisplatin treatment

Group Type: PLACEBO_COMPARATOR

Audiology

Intervention Type: BEHAVIORAL

otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

laboratory biomarker analysis

Intervention Type: BIOLOGICAL

Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

Placebo

Intervention Type: DRUG

Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.

Interventions

alpha-lipoic acid

Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.

Intervention Type: DRUG

Audiology

otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

Intervention Type: BEHAVIORAL

laboratory biomarker analysis

Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

Intervention Type: BIOLOGICAL

Placebo

Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.

Intervention Type: DRUG

Other Intervention Names

lipoic acid; ototoxicity monitoring; MDA

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn L Martin

Role: PRINCIPAL_INVESTIGATOR

Portland VA Medical Center, Portland, OR

Locations

VA Medical Center, Portland

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

CDR0000546570

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCRAR-VA-1810

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OHSU-3288

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

C4697-R

Identifier Type: -

Identifier Source: org_study_id

NCT00570596

Identifier Type: -

Identifier Source: nct_alias