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

NCT00477607 | Completed Phase 2 Results DMC

• 4 other identifiers: C4697-RCDR0000546570NCRAR-VA-1810OHSU-3288
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Ototoxicity; Unspecified Adult Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Ototoxicity Measurement

  Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement. ASHA criteria are defined as * 20 decibel (dB) increase at any test frequency, * 10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies.

  Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.

Secondary Outcomes (2)

• Malondialdehyde (MDA) Levels

  Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.

• Total Amount of Prescribed Cisplatin Dose Administered

  cisplatin treatment period between 10 weeks and up to 16 weeks.

Study Arms (2)

Arm 1

EXPERIMENTAL

Receiving alpha-lipoic acid during cisplatin treatment.

Drug: alpha-lipoic acid; Behavioral: Audiology; Biological: laboratory biomarker analysis

Arm 2

PLACEBO COMPARATOR

Receiving placebo during cisplatin treatment

Behavioral: Audiology; Biological: laboratory biomarker analysis; Drug: Placebo

Interventions

alpha-lipoic acid 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.

Also known as: lipoic acid

Arm 1

Audiology BEHAVIORAL

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

Also known as: ototoxicity monitoring

Arm 1; Arm 2

laboratory biomarker analysis BIOLOGICAL

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

Also known as: MDA

Arm 1; Arm 2

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Oregon Health and Science University: collaborator

Study Sites (2)

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Ototoxicity

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Limitations and Caveats

Missing data constraints have the number of subjects in the study being different for different outcomes.

Results Point of Contact

• Title: Dawn Konrad-Martin
• Organization: VA RR&D National Center for Rehbilitative Auditory Research

dawn.martin@va.gov

503-220-8262

Study Officials

• Dawn L Martin

  Portland VA Medical Center, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 7, 2014
• Results First Posted: January 29, 2014

Record last verified: 2014-02

Locations

US (2)