CClinicalTrials.gg
Sign In
CompletedNCT03243786Updated Nov 30, 2021

Stay on Track: A Study of Exercise Effects During Radiation

An interventional study of Lifestyle- Supportive Care in Breast Cancer, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 47 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • 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

    Behavioral: Lifestyle- Supportive Care

  • 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

    Behavioral: Lifestyle- Supportive Care

Interventions

  • BehavioralLifestyle- Supportive Care

    The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy

06

What researchers measure

Primary outcomes

  1. Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm

    Time frame: 6 months

Secondary outcomes

  1. Percent of participant retention thoughout the 12-week intervention through the six month follow-up

    Time frame: 6 months

  2. The percent of eligible patient who choose to take part in the study

    Time frame: 6 months

  3. Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm

    Time frame: 6 months

  4. Changes in lean soft tissue over the study period associated with intervention and activity

    Time frame: 6 months

  5. 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. Measures of physical activity (self-report and objective)

    Time frame: 6 months

  7. Dietary intake (assessed via Full Length Block Questionnaire)

    Time frame: 6 months

  8. Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)

    Time frame: 6 months

  9. Measures of skin side effects (CTCAE v4.0 Scoring)

    Time frame: 6 months

  10. Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity

    Time frame: 6 months

  11. Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity

    Time frame: 6 months

  12. Changes in biomarker (GM-CSF) associated with intervention and activity

    Time frame: 6 months

  13. Changes in biomarker (IFN-gamma) associated with intervention and activity

    Time frame: 6 months

  14. Changes in biomarker (IL-1alpha) associated with intervention and activity

    Time frame: 6 months

  15. Changes in biomarker (IL-1beta) associated with intervention and activity

    Time frame: 6 months

  16. Changes in biomarker (IL-4) associated with intervention and activity

    Time frame: 6 months

  17. Changes in biomarker (IL-6) associated with intervention and activity

    Time frame: 6 months

  18. Changes in biomarker (IL-8) associated with intervention and activity

    Time frame: 6 months

  19. Changes in biomarker (IL-10) associated with intervention and activity

    Time frame: 6 months

  20. Changes in biomarker (IL-12) associated with intervention and activity

    Time frame: 6 months

  21. Changes in biomarker (MCP-1) associated with intervention and activity

    Time frame: 6 months

  22. Changes in biomarker (TNF-alpha) associated with intervention and activity

    Time frame: 6 months

  23. Changes in biomarker (adiponectin) associated with intervention and activity

    Time frame: 6 months

  24. Changes in biomarker (leptin) associated with intervention and activity

    Time frame: 6 months

  25. Changes in biomarker (CRP) associated with intervention and activity

    Time frame: 6 months

  26. Changes in blood insulin level associated with intervention and activity

    Time frame: 6 months

  27. Changes in blood hemoglobin A1C level associated with intervention and activity

    Time frame: 6 months

  28. Changes in blood glucose level associated with intervention and activity

    Time frame: 6 months

07

Study locations

1 site
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03243786
Lead sponsor
Medical College of Wisconsin
Responsible party
John Longo (Assistant Professor Radiation Oncology, Medical College of Wisconsin) — Principal investigator
First posted
Aug 9, 2017
Start date
Apr 12, 2017
Primary completion
Sep 1, 2018
Completion
Oct 31, 2018
Last update
Nov 30, 2021

Study contacts

Carmen Bergom, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Medical College of Wisconsin

Start the discussion