Clinical trial · Interventional
Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study
Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study (EXACT)
- 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)
As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are becoming increasingly apparent. Most prominent are the toxic effects on the heart (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular disease (CVD). The investigators hypothesize that an individualized aerobic training program for cancer patients receiving active treatment will be both feasible and safe and will result in improvements in overall levels of physical activity and quality of life. Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates, along with program safety. Efficacy will be assessed by evaluating changes in health-related outcomes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heart; Disease, Functional | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderate Intensity Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Moderate Intensity Exercise
- description
- All consenting patients will participate in an aerobic training program, twice-weekly over a 12-week period. Assessments will be performed at baseline (pre-training) and post-program (12-weeks). All participants will continue to receive standard care for their cancer diagnosis.
- interventionNames
- Other: Moderate Intensity Exercise
Primary outcomes (2)
- measure
- Feasibility as measured by rate of recruitment
- timeFrame
- 12 Weeks
- description
- The rate of recruitment will be measured by comparing the number of patients screened to the number of patients enrolled (patients per month).
- measure
- Number of adverse events
- timeFrame
- 12 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria - Only those patients who meet the following inclusion will be asked to participate in the study: * Between the ages of 18 and 65; * Receiving anthracycline chemotherapeutic treatment for a primary/non-recurrent breast or hematological malignancy; * Are scheduled to received a minimum dose of 100 mg/m2 of doxorubicin (DOX) or 120 mg/m2 of daunorubicin (DAUN), or 150 mg/m2 epirubicin (EPI) * Within eight weeks of first anthracycline dose; * Do not have a previous history of myocardial infarction, cerebrovascular disease, peripheral vascular disease, congestive heart failure, or cardiomyopathy (controlled hypertension is not exclusionary); * Have no known contraindications to light-to-moderate exercise; * Have no known contraindications to cardiopulmonary exercise stress testing; * Able to participate in the 12-week community-based exercise program; * Provided medical consent from their treating physician Exclusion Criteria: * Any patients who meet the inclusion criteria, but have any significant cognitive limitations will be excluded from the study.
References
Publications (4)
- BACKGROUNDAlbini A, Pennesi G, Donatelli F, Cammarota R, De Flora S, Noonan DM. Cardiotoxicity of anticancer drugs: the need for cardio-oncology and cardio-oncological prevention. J Natl Cancer Inst. 2010 Jan 6;102(1):14-25. doi: 10.1093/jnci/djp440. Epub 2009 Dec 10. PMID 20007921
- BACKGROUNDYeh ET. Cardiotoxicity induced by chemotherapy and antibody therapy. Annu Rev Med. 2006;57:485-98. doi: 10.1146/annurev.med.57.121304.131240. PMID 16409162
- BACKGROUNDOeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185. PMID 17035650
- DERIVEDKeats MR, Grandy SA, Giacomantonio N, MacDonald D, Rajda M, Younis T. EXercise to prevent AnthrCycline-based Cardio-Toxicity (EXACT) in individuals with breast or hematological cancers: a feasibility study protocol. Pilot Feasibility Stud. 2016 Aug 5;2:44. doi: 10.1186/s40814-016-0084-9. eCollection 2016. PMID 27965861