Clinical trial · Observational
The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer
Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer
NCT02167932CI-TRIAL-00033203completedClinicalTrials.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)
This study will look at whether or not participating in a physical activity intervention during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a large increase after chemotherapy.
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 |
|---|---|---|---|
| Aging | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Walk With Ease | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Patients
- description
- Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment.
- interventionNames
- Behavioral: Walk With Ease
Primary outcomes (1)
- measure
- Compare the change in p16 from baseline to the end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in a previous study
- timeFrame
- One Year
- description
- Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in a previous study (LCCC810) of similar patients who did not participate in a physical activity intervention
Secondary outcomes (5)
- measure
- Measure the association of change in physical activity levels with change in with p16 levels from baseline to end of chemo and baseline to 6-months post.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * 21 to 59 years of age, female (A similar trial LCCC 1226 explores physical activity in women 60 years and older and is now in progress. * Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis) * Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen. * English speaking * IRB approved, signed written informed consent * Approval from their treating physician to engage in moderate-intensity physical activity * 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 or strength training intervention. * Unable to walk or engage in moderate-intensity physical activity.
References
Publications (1)
- DERIVEDNyrop KA, Page A, Deal AM, Wagoner C, Kelly EA, Kimmick GG, Copeland A, Speca J, Wood WA, Muss HB. Association of self-directed walking with toxicity moderation during chemotherapy for the treatment of early breast cancer. Support Care Cancer. 2023 Dec 28;32(1):68. doi: 10.1007/s00520-023-08275-4. PMID 38153568