Exercise in All ChemoTherapy

NCT ID: NCT03461471

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-03-30

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 an exercise intervention on the average chemotherapy patient and the patients compliance to the study.

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 adjuvant therapy and improves physical function and quality of life outcomes. Moderate exercise has been shown to improve fatigue (extreme tiredness), anxiety, and self-esteem. It also helps heart and blood vessel fitness, muscle strength, and body composition. However, despite guidance on implementing exercise recommendations for cancer patients, exercise counseling is still not standard of care in cancer centers across the U.S. Our goal is to collect data that will assist with translation of the evidence from randomized clinical trials into standard of care.

Conditions

Chemotherapy; Exercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

Exercise intervention

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

Exercise intervention

Interventions

Exercise Intervention

Exercise intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Schmitz

Professor, Public Health Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00005664

Identifier Type: -

Identifier Source: org_study_id