Status:
COMPLETED
Exercise in All ChemoTherapy
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Chemotherapy
Exercise
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Exercise in all Chemotherapy (EnACT) is a study to assess safety, feasibility, and acceptability of an exercise program within chemotherapy. This will be a single group study to capture the effects of...
Detailed Description
Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that exercise training is safe during primary a...
Eligibility Criteria
Inclusion
- Males and females ≥18 years of age
- Fluent in written and spoken English
- Must be able to provide and understand informed consent
- Must have an ECOG PS of ≤ 2
- Diagnosed with a solid tumor malignancy
- Cancer patients (stage 1-4)
- Scheduled to receive chemotherapy at Penn State Cancer Institute
- Absence of absolute contraindications for exercise according to the American Heart Association
- Primary attending oncologist approval
Exclusion
- Receiving chemotherapy at a location other than Penn State Cancer Institute
- Not fluent in written and spoken English
- Hematological malignancy
- Evidence in the medical record of an absolute contraindication for exercise
- Cardiac exclusion criteria:
- Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of chemotherapy
- Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for \>1 month prior to start of chemotherapy may be eligible
- syncope
- acute myocarditis, pericarditis, or endocarditis
- acute pulmonary embolus or pulmonary infarction
- thrombosis of lower extremities
- suspected dissecting aneurysm
- pulmonary edema
- respiratory failure
- acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
- mental impairment leading to inability to cooperate
- Non-English speaking
- Pregnant women
- Children (the protocol will only include individuals 18 and older)
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03461471
Start Date
April 1 2017
End Date
March 30 2019
Last Update
June 25 2019
Active Locations (1)
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1
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033