This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.
This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
28
A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription.
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Change in activity as measured by the Activity Log
A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis.
Time frame: from baseline to week 32
Received Dose Intensity of chemotherapy (RDI)
The RDI is calculated by (delivered dose)/(standard dose) x 100. Delivered dose = (actual total dose in mg/m2)/ (total days required to complete the treatment) Standard dose = (recommended total dose) / (total days planned to complete the treatment)
Time frame: 32 weeks
Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F
Fatigue as measured by the FACIT-F survey
Time frame: baseline (Day -28 to 1), week 24, 32 weeks
Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin
Time frame: baseline (Day -28 to 1), 32 weeks
Change from Baseline (day -28 to day 1) C-reactive protein
levels of C- reactive protein
Time frame: Baseline (day -28 to day 1) and week 32
Change from Baseline (Day -28 to day 1) Fasting insulin
Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32
Time frame: Baseline (day -28 to day 1) and week 32
Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day)
Time frame: baseline (day -28 to day 1) and week 32
Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score
Time frame: baseline (day -28 to day 1) and week 32
Change in Resting heart rate from baseline (day -28 to day 1)
Time frame: baseline (day -28 to day 1) and week 32
Change in Waist-hip ratio from baseline (day -28 to day 1)
Time frame: baseline (day -28 to day 1) and week 32
Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data
Average steps per week for weeks 1-32
Time frame: weekly for 32 weeks
Measures how likely a person is to continue with exercise prescription.
How the participant is feeling about the exercise.
Time frame: From baseline to Week 32
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