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Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Ototoxicity, Unspecified Adult Solid Tumor

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Trial Information

Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Ototoxicity measurement

Outcome Time Frame:

Baseline measurement will occur prior to first cisplatin treatment. Additional measurements will be completed before each subsequent cisplatin treatment. Follow-up measurement will occur at 1 and 3 months following the last cisplatin treatment.

Safety Issue:

No

Principal Investigator

Debra Wilmington, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Medical Center, Portland

Authority:

United States: Federal Government

Study ID:

C4697R

NCT ID:

NCT00477607

Start Date:

October 2007

Completion Date:

June 2011

Related Keywords:

  • Ototoxicity
  • Unspecified Adult Solid Tumor

Name

Location

Oregon Health & Science UniversityPortland, Oregon  97201
VA Medical Center, PortlandPortland, Oregon  97201