Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors

NCT00263861 | Completed DMC

• 3 other identifiers: CWRU6Z03P30CA043703CASE-CWRU-6Z03
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably. PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors.

Conditions

Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

neurotoxicity; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (6)

• Cutaneous sensation as measured by Semmes-Weinstein monofilaments

  baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

• Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument

  baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

• Vibration as measured by tuning fork

  baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

• Lower extremity muscle strength as measured by Dynamometer

  baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

• Blood pressure changes

  baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

• Glycemic control as measured by Glycosylated Hemoglobin Assay

  baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

Interventions

management of therapy complications PROCEDURE

Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of solid tumor * Metastatic disease (stage IV) * Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following: * Taxane (paclitaxel or docetaxel) * Platinum (cisplatin, carboplatin, or oxaliplatin) * Diagnosis of type I or II diabetes mellitus PATIENT CHARACTERISTICS: Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No other disease that reduces peripheral nerve function (e.g., HIV/AIDS, uremia, spinal injuries, alcoholism, or CNS problems) PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics * No prior chemotherapy * No prior or concurrent neurotoxic drugs (i.e., vincristine)

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, 44106-5047, United States

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Constance Visovsky, PhD, RN, ACNP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2005
• First Posted: December 9, 2005
• Study Start: March 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)