Clinical trial · Interventional
Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study
NCT07203378CI-TRIAL-00123011ENERGIZErecruitingPhase 2ClinicalTrials.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 goal of this study is to test the efficacy of using a 12-week, home-based, unsupervised aerobic and resistance training exercise program for changes in cancer-related fatigue in patients with metastatic breast cancer who are receiving Enhertu.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole-body resistance training and aerobic exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise Intervention
- interventionNames
- Other: Whole-body resistance training and aerobic exercise
- type
- NO_INTERVENTION
- label
- Usual Care
Primary outcomes (1)
- measure
- Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score from baseline to Week 13 (end of exercise intervention).
- timeFrame
- 13 weeks
- description
- Test the preliminary efficacy of a 12-week, home-based, unsupervised aerobic and resistance training exercise program on changes in cancer-related fatigue, in patients with a diagnosis of locally advanced/unresectable or metastatic breast cancer and patients with High-Risk HER 2+ breast cancer after completion of neoadjuvant chemotherapy who are receiving Enhertu therapy. FACIT Fatigue Scored 0 (not at all)- 4(Very Much).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject aged ≥ 18 years * Diagnosis of locally advanced/unresectable or metastatic breast cancer. Note: Patients with High-Risk HER-2 + breast cancer after completion of neoadjuvant chemotherapy requiring adjuvant Enhertu are allowed at the discretion of the treating physician. * Has received 3 or 4 cycles of Enhertu and is expected to continue treatment for at least 12 weeks. Note: HER-2 targeted systemic therapy (e.g. Trastuzumab and/or Pertuzumab) in conjunction with Enhertu is allowed. * Able and willing to participate in the interventional aerobic exercise and resistance exercises. * Currently following standard of care contraception requirements and willing to continue following these requirements for the duration of therapy. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * Experiencing clinical fatigue symptoms in the opinion of the investigator. * Subject has completed the ACSM exercise preparticipation health screening and is, in the opinion of the investigator, fit to participate in this study. Exclusion Criteria: -Currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training ≥ two days per week. * Structured is defined as time set aside in the subject's day to workout. * Resistance training is defined as exercises which use weights, bands, or body weight (e.g., squats or push-ups). AND Currently participating in structured moderate-intensity aerobic exercise for ≥ 150 minutes per week. * Moderate-intensity exercise is defined as activities where the subject can talk but not sing. * Aerobic exercise includes, but is not limited to, walking, swimming, cycling, running, rowing, hiking, and elliptical. * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study. * Participants taking prohibited medications as described in Section 7.4.1.
References
Publications (0)
Data not yet available
No reference posted for this study.