A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02159157|
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Early Stage Breast Cancer||Behavioral: Exercise prescription||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||December 31, 2018|
No Intervention: Arm A
Physical Therapy consult for post op care and general physical activity recommendation 1-4 weeks prior to starting chemotherapy.
Phone calls designed to support the patient to maintain current activity level.
Placebo Comparator: Arm B
Physical Therapy consult for post-op care 1-4 weeks prior to starting chemotherapy.
Exercise prescription aimed at increasing physical activity by a minimum of 10 MET hours/week.
Motivational phone calls aimed at encouraging the patient to adhere to their exercise prescription.
Behavioral: Exercise prescription
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.
- Change in activity as measured by the Activity Log [ Time Frame: from baseline to week 32 ]A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis.
- Received Dose Intensity of chemotherapy (RDI) [ Time Frame: 32 weeks ]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)
- Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F [ Time Frame: baseline (Day -28 to 1), week 24, 32 weeks ]Fatigue as measured by the FACIT-F survey
- 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 [ Time Frame: Baseline (day -28 to day 1) and week 32 ]levels of C- reactive protein
- Change from Baseline (Day -28 to day 1) Fasting insulin [ Time Frame: Baseline (day -28 to day 1) and week 32 ]Fasting insulin levels measured in blood at 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 [ Time Frame: weekly for 32 weeks ]Average steps per week for weeks 1-32
- Measures how likely a person is to continue with exercise prescription. [ Time Frame: From baseline to Week 32 ]How the participant is feeling about the exercise.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159157
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Mary Chamberlin, MD||Dartmouth-Hitchcock Medical Center|