Back to resultsA Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer
Primary Purpose
Early Stage Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise prescription
Sponsored by
About this trial
This is an interventional supportive care trial for Early Stage Breast Cancer focused on measuring breast cancer, exercise
Eligibility Criteria
Inclusion Criteria:
- Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
- Patients must have recovered from prior surgery.
- Patients must be able to walk unassisted without oxygen
- Patients must complete the Physical Activity Readiness questionnaire with "No" answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study.
- Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
- Karnofsky performance status > or = to 80%.
- Previous or ongoing Physical therapy treatments are acceptable.
- Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
- Participants must have a baseline activity level of < 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the LTEQ (leisure time exercise questionnaire) for physical activity (completed during screening).
Exclusion Criteria:
- Patients less than 18 years of age.
- Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
- Patients who are oxygen dependent.
- Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
- Patients with a Karnofsky performance status of < 80%.
- Pregnant.
- Unable to read or write in English.
Sites / Locations
- Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Placebo Comparator
Arm Label
Arm A
Arm B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F
Fatigue as measured by the FACIT-F survey
Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin
Change from Baseline (day -28 to day 1) C-reactive protein
levels of C- reactive protein
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
Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day)
Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score
Change in Resting heart rate from baseline (day -28 to day 1)
Change in Waist-hip ratio from baseline (day -28 to day 1)
Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data
Average steps per week for weeks 1-32
Measures how likely a person is to continue with exercise prescription.
How the participant is feeling about the exercise.
Full Information
NCT ID
NCT02159157
First Posted
May 5, 2014
Last Updated
August 19, 2020
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02159157
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Breast Cancer
Keywords
breast cancer, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
No Intervention
Arm Description
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.
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise prescription
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in activity as measured by the Activity Log
Description
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
Secondary Outcome Measure Information:
Title
Received Dose Intensity of chemotherapy (RDI)
Description
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
Title
Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F
Description
Fatigue as measured by the FACIT-F survey
Time Frame
baseline (Day -28 to 1), week 24, 32 weeks
Title
Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin
Time Frame
baseline (Day -28 to 1), 32 weeks
Title
Change from Baseline (day -28 to day 1) C-reactive protein
Description
levels of C- reactive protein
Time Frame
Baseline (day -28 to day 1) and week 32
Title
Change from Baseline (Day -28 to day 1) Fasting insulin
Description
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
Title
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
Title
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
Title
Change in Resting heart rate from baseline (day -28 to day 1)
Time Frame
baseline (day -28 to day 1) and week 32
Title
Change in Waist-hip ratio from baseline (day -28 to day 1)
Time Frame
baseline (day -28 to day 1) and week 32
Title
Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data
Description
Average steps per week for weeks 1-32
Time Frame
weekly for 32 weeks
Title
Measures how likely a person is to continue with exercise prescription.
Description
How the participant is feeling about the exercise.
Time Frame
From baseline to Week 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
Patients must have recovered from prior surgery.
Patients must be able to walk unassisted without oxygen
Patients must complete the Physical Activity Readiness questionnaire with "No" answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study.
Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
Karnofsky performance status > or = to 80%.
Previous or ongoing Physical therapy treatments are acceptable.
Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
Participants must have a baseline activity level of < 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the LTEQ (leisure time exercise questionnaire) for physical activity (completed during screening).
Exclusion Criteria:
Patients less than 18 years of age.
Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
Patients who are oxygen dependent.
Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
Patients with a Karnofsky performance status of < 80%.
Pregnant.
Unable to read or write in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Chamberlin, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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