- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03243786
Stay on Track: A Study of Exercise Effects During Radiation
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 12-week "Stay on Track" intervention
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 intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
|
ACTIVE_COMPARATOR: 12-week self-guided control
The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
|
The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of participant retention thoughout the 12-week intervention through the six month follow-up
Time Frame: 6 months
|
6 months
|
The percent of eligible patient who choose to take part in the study
Time Frame: 6 months
|
6 months
|
Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm
Time Frame: 6 months
|
6 months
|
Changes in lean soft tissue over the study period associated with intervention and activity
Time Frame: 6 months
|
6 months
|
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
|
6 months
|
Measures of physical activity (self-report and objective)
Time Frame: 6 months
|
6 months
|
Dietary intake (assessed via Full Length Block Questionnaire)
Time Frame: 6 months
|
6 months
|
Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)
Time Frame: 6 months
|
6 months
|
Measures of skin side effects (CTCAE v4.0 Scoring)
Time Frame: 6 months
|
6 months
|
Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (GM-CSF) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IFN-gamma) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IL-1alpha) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IL-1beta) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IL-4) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IL-6) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IL-8) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IL-10) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (IL-12) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (MCP-1) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (TNF-alpha) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (adiponectin) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (leptin) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in biomarker (CRP) associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in blood insulin level associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in blood hemoglobin A1C level associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Changes in blood glucose level associated with intervention and activity
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carmen Bergom, MD, Medical College of Wisconsin
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00027661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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