Clinical trial · Interventional
Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy
NCT02796365CI-TRIAL-00036116HF-PROACTIVEcompletedN/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 identify patients at risk for future heart failure using novel markers of early cardiac damage and determine if exercise training can improve these emerging markers as well as overall fitness and quality of life.
Conditions
Conditions (4)
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 |
| Doxorubicin Induced Cardiomyopathy | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise
- description
- Patients will participate in a 10 week outpatient cardiac rehabilitation program. Exercise will consist of 3 days per week of interval training on a treadmill or bike at an intensity between 50-90% of heart rate reserve. Additionally patients will perform resistance exercises 1-2 days per week and attend 8 nutrition and lifestyle classes.
- interventionNames
- Other: Exercise
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Control group will not be instructed on exercise, but encouraged to follow standard medical advice.
Primary outcomes (1)
- measure
- Left ventricular strain
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cancer who are undergoing or have completed the chemotherapy drugs doxorubicin and/or trastuzumab. * Have had a recent echocardiogram with a relative reduction in LV strain of \>10%. * If no recent echocardiogram, have a troponin value \>0.04 ng/mL, or an increase of 0.04 ng/mL if baseline troponin is elevated. * Age \>/= 18 years. * Eastern Cooperative Oncology Group (ECOG) scale 0-2. * Males and females. Exclusion Criteria: * Patients with an Ejection Fraction \<50% * Patients not deemed appropriate by a cardiologist or oncologist * Patients with an ECOG scale \>2 * Inability to perform exercise * Patients who already report exercising \>2days per week for \>29 minutes
References
Publications (1)
- DERIVEDKerrigan DJ, Reddy M, Walker EM, Cook B, McCord J, Loutfi R, Saval MA, Baxter J, Brawner CA, Keteyian SJ. Cardiac Rehabilitation Improves Fitness in Patients With Subclinical Markers of Cardiotoxicity While Receiving Chemotherapy: A RANDOMIZED CONTROLLED STUDY. J Cardiopulm Rehabil Prev. 2023 Mar 1;43(2):129-134. doi: 10.1097/HCR.0000000000000719. Epub 2022 Aug 4. PMID 35940850