Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00281853
First received: January 24, 2006
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer.


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: Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment [ Time Frame: baseline, and then weeks 4, 8, and 12 during study treatment ] [ Designated as safety issue: No ]
  • Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment [ Time Frame: baseline, and then weeks 4, 8, and 12 during study treatment ] [ Designated as safety issue: No ]
  • Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment [ Time Frame: baseline, and then weeks 4, 8, and 12 during study treatment ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: management of therapy complications
    Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
Detailed Description:

OBJECTIVES:

  • Determine the change in peripheral nerve function in cancer patients during and after treatment with chemotherapy or biologic therapy.
  • Determine the clinical measurement of hearing-related air and bone conduction and vibratory sensation in these patients.
  • Correlate the changes in orthostatic blood pressure using both the Vasotrac automated blood pressure device and the standard clinical automated blood pressure equipment.
  • Determine the patient's perception of hearing quality before and after treatment with chemotherapy or biologic therapy.

OUTLINE: This is a multicenter study.

Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who are receiving chemotherapy or biological therapy for cancer.

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of cancer
  • Scheduled to be treated with 1 of the following agents:

    • Cisplatin/paclitaxel combination
    • Biologic therapy with high-dose interferon alfa

PATIENT CHARACTERISTICS:

  • Normal vision OR vision corrected with glasses or contact lenses
  • No diseases or disorders reducing peripheral nerve function, including any of the following:

    • Diabetes mellitus
    • HIV/AIDS
    • Uremia
    • Spinal injuries
    • Alcoholism
    • CNS problems
  • No hearing impairment

PRIOR CONCURRENT THERAPY:

  • No prior biologic therapy or neurotoxic chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281853

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Constance Visovsky, PhD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Constance Visovsky, PhD, RN, ACNP, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00281853     History of Changes
Other Study ID Numbers: CASE13Z04, P30CA043703, CASE-13Z04, CASE-120411
Study First Received: January 24, 2006
Last Updated: June 10, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
neurotoxicity
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 21, 2014