Study Title: Fatigue Symptom Control: Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy (URCC 08106)
Category: Cancer Control/Symptom Prevention
Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.
Principal Investigator: Jacqueline Vuky
Study Coordinator: Lorena Barajas
Phone: 206-341-1044
Email: cancerresearch@vmmc.org
What is the Fatigue Symptom Control: Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy (URCC 08106) study?
This is a multicenter study. Patients are stratified according to participating CCOP site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue reported on the study assessment questionnaire (? 5 vs > 5). Patients are randomized to 1 of 2 intervention arms. Arm I: Patients receive standard chemotherapy. Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo moderately intense aerobic exercise (walking) monitored by a pedometer, and low to moderately intense progressive-resistance exercise using therapeutic resistance bands for 6 weeks. Patients also receive standard chemotherapy. Patients in both arms undergo assessment of their aerobic capacity and strength by the 6-minute walk test and handgrip dynamometry at baseline and at day 41. Patients also complete Functional Assessment of Chronic Illness Therapy-Fatigue and -Cognitive Subscales, Brief Fatigue Inventory, Multidimensional Fatigue Symptom Inventory, Center for Epidemiological Studies-Depression Scale State Trait Anxiety Inventory, Pittsburgh Sleep Quality Inventory, Profile of Mood States, Aerobic Center Longitudinal Study Physical Activity, and Symptom Inventory questionnaires at baseline and at day 41 and keep a daily exercise diary during study intervention.
Who can participate?
· Starting chemotherapy lasting at least 6 weeks
· Patient must be consented AT LEAST 5 days prior to first chemo tx
· Chemotherapy cycles must be 2 or 3 weeks long
· KPS ? 70% with no metastatic disease
· No concurrent RT or chemotherapy within last 6 months
· No physical limitations to a low-moderate intensity at home exercise program
· No patients who currently exercise regularly (defined as planned physical activity 3-5 times a week for 20-60 minutes)
Study Summary:
This randomized phase III trial is studying how well exercise works in lessening fatigue caused by cancer in patients undergoing chemotherapy.
Detailed Study Description:
Physical activity may help lessen fatigue caused by cancer in patients receiving chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise program is effective in lessening fatigue.
Study Design: Interventional
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Fatigue
Intervention Type: Behavioral
Intervention Name: Exercise
Gender: Male
Age group: Interventional
Sponsor: University of Rochester and the National Cancer Institute
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