Clinical trial · Interventional
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
NCT03243786CI-TRIAL-00055280completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle- Supportive Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 12-week "Stay on Track" intervention
- description
- 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
- interventionNames
- Behavioral: Lifestyle- Supportive Care
- type
- ACTIVE_COMPARATOR
- label
- 12-week self-guided control
- description
- The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
- interventionNames
- Behavioral: Lifestyle- Supportive Care
Primary outcomes (1)
- measure
- Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.