Clinical trial · Interventional
The Effect of Walking on Fatigue During Radiotherapy in Breast Cancer Patients 65 and Older
Phase 2 Randomized Study of a Walking Intervention for Radiation-related Fatigue Among Breast Cancer Patients Receiving Adjuvant Radiation
- 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)
This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery. Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women in both arms will complete a number of surveys including questionnaires on fatigue, pain, depression, sleep, and social support. In addition, a blood sample will be collected prior to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of inflammatory biomarkers, and their potential association with exercise and fatigue.
Conditions
Conditions (2)
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 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Walk With Ease Arm A | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Women randomized to the WWE program will receive a workbook, and a daily walking log, the latter to be completed during the study.
- interventionNames
- Behavioral: Walk With Ease Arm A
- type
- NO_INTERVENTION
- label
- Arm B
- description
- Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy
Primary outcomes (1)
- measure
- Compare the change in treatment related fatigue from baseline to last week of radiotherapy between patients in the WWE intervention and usual care arms using the Fatigue Symptom Index (FSI).
- timeFrame
- Four months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ≥65 years of age * Histologically confirmed Stage I, II or III breast cancer status post breast surgery with or without adjuvant chemotherapy. * Scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall. * English speaking. * IRB approved, signed written informed consent. * Approval from their treating radiation oncologist to engage in moderate-intensity physical activity. This will be obtained by the study research coordinator and documented on the study screening form (attached). * Patient-assessed ability to walk and engage in moderate physical activity Willing and able to meet all study requirements. Exclusion Criteria: * One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention. * Receiving accelerated partial breast irradiation. * Unable to walk or engage in moderate-intensity physical activity. * Already participated in Walk with Ease Program. * Already actively walking (≥120 minutes per week).
References
Publications (0)
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