Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00305799
First received: March 21, 2006
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: management of therapy complications |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Dizziness and Vertigo
Hearing Disorders and Deafness
Peripheral Nerve Disorders
Drug Information available for:
Oxaliplatin
U.S. FDA Resources
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- 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 [ Time Frame: every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment ] [ Designated as safety issue: No ]
- 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 [ Time Frame: every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment ] [ Designated as safety issue: No ]
| Enrollment: | 59 |
| Study Start Date: | November 2005 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: management of therapy complications
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.
OBJECTIVES:
- Define the prevalence of audiometrically detectable hearing loss in patients with solid tumors treated with oxaliplatin.
- Describe the association of chemotherapy-induced peripheral neuropathy (CIPN) and audiometrically detectable hearing loss in these patients.
- Describe the association of CIPN and patient self-reported scales including, Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory.
OUTLINE: This is an exploratory study.
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.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary care clinic
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305799
Locations
| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Study Chair: | Sabarish Ayyappan, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00305799 History of Changes |
| Other Study ID Numbers: | CASE3Y05, P30CA043703, CASE3Y05, 10-05-19 |
| Study First Received: | March 21, 2006 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Case Comprehensive Cancer Center:
|
neurotoxicity unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neurotoxicity Syndromes Neoplasms Nervous System Diseases Poisoning Substance-Related Disorders |
Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013