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.