Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy

Completed · Not applicable

Conditions studied: Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Stomach Cancer, Esophageal Cancer

In brief

This randomized, controlled, pilot experiment will evaluate the effects of an aerobic walking intervention on OIPN (oxaliplatin-induced peripheral neuropathy) in patients with gastrointestinal (GI) cancer who are already prescribed oxaliplatin (85 mg/m2 every other week for at least six cycles) by their oncologists. Oxaliplatin is a standard chemotherapy treatment for invasive GI cancers that causes OIPN in 85-95% of patients.

Key facts

Study ID

NCT03515356

Run by

University of Michigan Rogel Cancer Center

People needed

54

Starts

2018-06-13

Expected to finish

2019-06-24

Last updated by the study team

2020-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed GI cancer (e.g, colorectal, gastric, pancreatic, esophageal, bowel);
• Scheduled to receive at least 6 cycles of oxaliplatin (85 mg/m2);
• Receiving care at the University of Michigan or St. Joseph Cancer Clinics;
• A Karnofsky Performance Status ≥ 80% or an Eastern Cooperative Oncology Group Status 0 to 1;
• Voluntarily consented to participate in all intervention components.

You may not qualify if…

• Exercise- or mobility-limiting cardiovascular, pulmonary, musculoskeletal, or psychological disease, based on the EMR (electronic medical record) past medical history and consultation with the medical oncologist;
• Scheduled major surgery during the study time period;
• Pre-existing peripheral neuropathy prior to chemotherapy (potentially due to diabetes, central nervous system malignancy, vitamin deficiency, heredity, nerve compression injury, non-surgically corrected carpal tunnel disease, or alcohol dependence) per patient self-report in response to brief screening questions noted in the pre-screening section;
• Pregnancy;
• Inability to read or speak English;
• Prognosis of less than three months.

Where it is running

• The University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• St. Joseph Mercy Brighton Health Center — Brighton, Michigan, United States
• Brighton Center for Specialty Care — Brighton, Michigan, United States
• St. Joseph Mercy Health System — Canton, Michigan, United States
• St. Joseph Mercy Chelsea Cancer Center — Chelsea, Michigan, United States
• The University of Michigan Northville Health Center — Northville, Michigan, United States

Full record on ClinicalTrials.gov

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