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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle- Supportive Care	The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy

Timeline

• Start date: 2017-04-12
• Primary completion: 2018-09-01
• Completion: 2018-10-31
• First posted: 2017-08-09
• Last updated: 2021-11-30

Locations

1 site across 1 country: United States