Clinical trial NCT00477607: Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
Official title: Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ototoxicity
Unspecified Adult Solid Tumor
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2007-05-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Ototoxicity Measurement
timeFrame: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.
Secondary outcomes:
measure: Malondialdehyde (MDA) Levels
timeFrame: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.
measure: Total Amount of Prescribed Cisplatin Dose Administered
timeFrame: cisplatin treatment period between 10 weeks and up to 16 weeks.
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Portland VA Medical Center, Portland, OR
name: Dawn L Martin
role: PRINCIPAL_INVESTIGATOR
References: