Stay on Track: A Study of Exercise Effects During Radiation

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243786
• Other study ID #: PRO00027661
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: November 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 31, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. > 18 years of age;

2. confirmed primary non-metastatic breast adenocarcinoma;

3. planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;

4. planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;

5. Have a Karnovsky Performance Score of 70 or above (see Appendix)

6. 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;

7. have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);

8. understand and speak English;

9. physically able to engage in the intervention;

10. accepting of randomization (Note that anti-estrogen therapy is allowed.)

Exclusion Criteria:

1. Patients who have metastatic disease;

2. Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.

3. Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.

4. Patients who have received chemotherapy for their breast cancer.

5. Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm		6 months
Secondary	Percent of participant retention thoughout the 12-week intervention through the six month follow-up		6 months
Secondary	The percent of eligible patient who choose to take part in the study		6 months
Secondary	Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm		6 months
Secondary	Changes in lean soft tissue over the study period associated with intervention and activity		6 months
Secondary	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		6 months
Secondary	Measures of physical activity (self-report and objective)		6 months
Secondary	Dietary intake (assessed via Full Length Block Questionnaire)		6 months
Secondary	Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)		6 months
Secondary	Measures of skin side effects (CTCAE v4.0 Scoring)		6 months
Secondary	Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity		6 months
Secondary	Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity		6 months
Secondary	Changes in biomarker (GM-CSF) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IFN-gamma) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IL-1alpha) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IL-1beta) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IL-4) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IL-6) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IL-8) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IL-10) associated with intervention and activity		6 months
Secondary	Changes in biomarker (IL-12) associated with intervention and activity		6 months
Secondary	Changes in biomarker (MCP-1) associated with intervention and activity		6 months
Secondary	Changes in biomarker (TNF-alpha) associated with intervention and activity		6 months
Secondary	Changes in biomarker (adiponectin) associated with intervention and activity		6 months
Secondary	Changes in biomarker (leptin) associated with intervention and activity		6 months
Secondary	Changes in biomarker (CRP) associated with intervention and activity		6 months
Secondary	Changes in blood insulin level associated with intervention and activity		6 months
Secondary	Changes in blood hemoglobin A1C level associated with intervention and activity		6 months
Secondary	Changes in blood glucose level associated with intervention and activity		6 months