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

NCT00281853 | Completed DMC

• 4 other identifiers: CASE13Z04P30CA043703CASE-13Z04CASE-120411
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

neurotoxicity; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

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.

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are receiving chemotherapy or biological therapy for cancer.

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

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 (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Constance Visovsky, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: March 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)