Stay on Track: A Study of Exercise Effects During Radiation
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle- Supportive Care
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- > 18 years of age;
- confirmed primary non-metastatic breast adenocarcinoma;
- planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;
- planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;
- Have a Karnovsky Performance Score of 70 or above (see Appendix)
- Patient's Body Mass Index (BMI) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week AND 2 weekly sessions of resistance exercise;
- have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);
- understand and speak English;
- physically able to engage in the intervention;
- accepting of randomization (Note that anti-estrogen therapy is allowed.)
Exclusion Criteria:
- Patients who have metastatic disease;
- Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.
- Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.
- Patients who have received chemotherapy for their breast cancer.
- Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
Sites / Locations
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
12-week "Stay on Track" intervention
12-week self-guided control
Arm Description
The study intervention includes three personal exercise training sessions, three dietary counseling sessions, use of a physical activity tracking device, and approximately three weekly text messaging
The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
Outcomes
Primary Outcome Measures
Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm
Secondary Outcome Measures
Percent of participant retention thoughout the 12-week intervention through the six month follow-up
The percent of eligible patient who choose to take part in the study
Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm
Changes in lean soft tissue over the study period associated with intervention and activity
Changes in BMI (weight and height will be combined to report BMI in kg/m^2) over the study period associated with intervention and activity
Measures of physical activity (self-report and objective)
Dietary intake (assessed via Full Length Block Questionnaire)
Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)
Measures of skin side effects (CTCAE v4.0 Scoring)
Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity
Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity
Changes in biomarker (GM-CSF) associated with intervention and activity
Changes in biomarker (IFN-gamma) associated with intervention and activity
Changes in biomarker (IL-1alpha) associated with intervention and activity
Changes in biomarker (IL-1beta) associated with intervention and activity
Changes in biomarker (IL-4) associated with intervention and activity
Changes in biomarker (IL-6) associated with intervention and activity
Changes in biomarker (IL-8) associated with intervention and activity
Changes in biomarker (IL-10) associated with intervention and activity
Changes in biomarker (IL-12) associated with intervention and activity
Changes in biomarker (MCP-1) associated with intervention and activity
Changes in biomarker (TNF-alpha) associated with intervention and activity
Changes in biomarker (adiponectin) associated with intervention and activity
Changes in biomarker (leptin) associated with intervention and activity
Changes in biomarker (CRP) associated with intervention and activity
Changes in blood insulin level associated with intervention and activity
Changes in blood hemoglobin A1C level associated with intervention and activity
Changes in blood glucose level associated with intervention and activity
Full Information
NCT ID
NCT03243786
First Posted
February 16, 2017
Last Updated
November 18, 2021
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT03243786
Brief Title
Stay on Track: A Study of Exercise Effects During Radiation
Official Title
Stay on Track: A Pilot Study of the Effects of Exercise on Mitigating Side Effects and Altering Inflammatory Biomarker Profiles During Radiation Therapy for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the impact of a lifestyle intervention. The study will examine the Stay on Track program, dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy.
Detailed Description
Research Design. The investigators will be conducting an randomized trial in 60 women undergoing radiation treatment for breast cancer to examine the feasibility of a 12-week lifestyle intervention that addresses diet and physical activity and to explore the impact on behavioral, biological and psychosocial outcomes.
Procedure Summary. Patients who are eligible are consented by the research coordinator, after which a baseline assessment will be scheduled. The baseline assessment requires 60 minutes and includes questionnaires, height/weight, dual energy x-ray absorptiometry (DEXA), and phlebotomy. Participants will also wear the Fitbit for one week to establish baseline activity level. After the baseline assessment, women are then randomly assigned to: the 12-week "Stay on Track" lifestyle intervention or the 12-week self-guided control. Both groups complete a post-intervention and a 3-month follow-up visit identical to their baseline assessment. Self-guided controls can utilize their Fitbit and will receive informative binders 24 weeks' post-intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12-week "Stay on Track" intervention
Arm Type
Active Comparator
Arm Description
The study intervention includes three personal exercise training sessions, three dietary counseling sessions, use of a physical activity tracking device, and approximately three weekly text messaging
Arm Title
12-week self-guided control
Arm Type
Active Comparator
Arm Description
The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle- Supportive Care
Intervention Description
The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
Primary Outcome Measure Information:
Title
Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent of participant retention thoughout the 12-week intervention through the six month follow-up
Time Frame
6 months
Title
The percent of eligible patient who choose to take part in the study
Time Frame
6 months
Title
Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm
Time Frame
6 months
Title
Changes in lean soft tissue over the study period associated with intervention and activity
Time Frame
6 months
Title
Changes in BMI (weight and height will be combined to report BMI in kg/m^2) over the study period associated with intervention and activity
Time Frame
6 months
Title
Measures of physical activity (self-report and objective)
Time Frame
6 months
Title
Dietary intake (assessed via Full Length Block Questionnaire)
Time Frame
6 months
Title
Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)
Time Frame
6 months
Title
Measures of skin side effects (CTCAE v4.0 Scoring)
Time Frame
6 months
Title
Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity
Time Frame
6 months
Title
Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (GM-CSF) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IFN-gamma) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IL-1alpha) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IL-1beta) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IL-4) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IL-6) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IL-8) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IL-10) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (IL-12) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (MCP-1) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (TNF-alpha) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (adiponectin) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (leptin) associated with intervention and activity
Time Frame
6 months
Title
Changes in biomarker (CRP) associated with intervention and activity
Time Frame
6 months
Title
Changes in blood insulin level associated with intervention and activity
Time Frame
6 months
Title
Changes in blood hemoglobin A1C level associated with intervention and activity
Time Frame
6 months
Title
Changes in blood glucose level associated with intervention and activity
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female Breast Cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 18 years of age;
confirmed primary non-metastatic breast adenocarcinoma;
planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;
planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;
Have a Karnovsky Performance Score of 70 or above (see Appendix)
Patient's Body Mass Index (BMI) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week AND 2 weekly sessions of resistance exercise;
have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);
understand and speak English;
physically able to engage in the intervention;
accepting of randomization (Note that anti-estrogen therapy is allowed.)
Exclusion Criteria:
Patients who have metastatic disease;
Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.
Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.
Patients who have received chemotherapy for their breast cancer.
Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Bergom, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Stay on Track: A Study of Exercise Effects During Radiation
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