Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

NCT00305799 | Completed

• 3 other identifiers: CASE3Y05P30CA04370310-05-19
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Understanding how oxaliplatin affects hearing loss, dizziness, and peripheral neuropathy may improve the ability to plan effective treatment for patients receiving oxaliplatin for solid tumors. PURPOSE: This clinical trial is studying hearing loss and dizziness in patients receiving oxaliplatin for solid tumors.

Conditions

Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

neurotoxicity; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Hearing loss as measured by Hearing Loss Inventory, Dizziness Handicap Inventory, and audiogram every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

  every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

• Peripheral neuropathy as measured by Peripheral Neuropathy Scale every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

  every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

Interventions

management of therapy complications PROCEDURE

Patients will complete three self-reported questionnaires including the Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. Patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. Patients will also undergo a hearing test.

Eligibility Criteria

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

Study Population

Primary care clinic

DISEASE CHARACTERISTICS: * Diagnosis of solid tumor * Received an oxaliplatin-containing chemotherapy regimen within the past 15 months\* NOTE: \*If oxaliplatin was omitted from the patient's most recent chemotherapy regimen due to ototoxicity, the patient is still eligible for participation in this study * No known CNS metastases PATIENT CHARACTERISTICS: * No history of spinal injuries * ECOG performance status 0-3 * No history of chronic renal failure * No known HIV/AIDS PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Sabarish Ayyappan, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: November 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: November 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

US (2)