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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00281853

Enrollment

Registered

2006-01-25

Start date

2005-03-31

Completion date

2007-08-31

Last updated

2010-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

neurotoxicity, unspecified adult solid tumor, protocol specific

Brief summary

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.

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.

Interventions

PROCEDUREmanagement 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment	baseline, and then weeks 4, 8, and 12 during study treatment
Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment	baseline, and then weeks 4, 8, and 12 during study treatment
Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment	baseline, and then weeks 4, 8, and 12 during study treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026