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Completed

NCT Number: NCT00281853

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

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

management of therapy complications

Procedure

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 25, 2006
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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