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Breast CancerNCT03243786

Stay on Track: A Study of Exercise Effects During Radiation

A study testing Lifestyle- Supportive Care in people with Breast Cancer, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Lifestyle- Supportive Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
12 Apr 2017to 31 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 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;
Show all 10Show fewer
  • 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.)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

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

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.

Conditions
Breast Cancer
Being tested
Lifestyle- Supportive Care
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle- Supportive CareBehavioural

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

Study groups in NCT03243786
Study groupRoleWhat they receive
12-week "Stay on Track" interventionActive comparatorThe 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
Receives: Behavioral: Lifestyle- Supportive Care
12-week self-guided controlActive comparatorThe self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
Receives: Behavioral: Lifestyle- Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (28)

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start12 Apr 2017
  3. Primary completion1 Sep 2018
  4. Study completion31 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03243786
Sponsor's protocol ID
PRO00027661
Status last verified
Nov 2021
First submitted
16 Feb 2017
Last updated
30 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle- Supportive Care in people with Breast Cancer, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03243786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

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Clinical Trial NCT03243786 | AzTrials