Status:
COMPLETED
Stay on Track: A Study of Exercise Effects During Radiation
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 qualit...
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 th...
Eligibility Criteria
Inclusion
- \> 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
- 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.
Key Trial Info
Start Date :
April 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03243786
Start Date
April 12 2017
End Date
October 31 2018
Last Update
November 30 2021
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226