Exercise in All ChemoTherapy (EnACT)

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Exercise
• Intervention / Treatment: Behavioral: Exercise Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Exercise intervention	Behavioral: Exercise Intervention; Exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Feasibility	Feasibility will be obtained if one third of chemotherapy patients actually do the exercise prescribed (one exercise session per week for four weeks).	Feasibility will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare changes in pain, physical function, nausea, vomiting, arthralgias, chemotherapy alterations (dose delays and alterations).	This will be compared using surveys at the beginning and end of chemotherapy (or intervention). Data will also be collected on the initial chemotherapy prescription and whether there are dose alterations.	Surveys will be given once the patient is consented and again at the completion of the study for each patient (average of 5 months per patient).
Qualitative assessments of clinician perspectives regarding the study. At the end of the study clinicians will be asked a series of qualitative questions to gain their insight into the study.	At the conclusion of the study, clinicians within the institution will be asked qualitative questions regarding the study.	Surveys will be provided to clinicians at the completion of the study (up to 38 months)
Assessing safety through number of patients with injuries related to the intervention	The investigator will be using a standardized Adverse Events/Injury History survey as the primary instrument in assessing safety. This survey focuses on asking questions to gauge the participants experience with muscle strain, joint pain, among other things, in order to assess if there were any complications associated with the intervention. The investigator will consider the intervention safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).	A standardized survey for assessing injuries will be used and administered at the end of the patients chemotherapy (average of 5 months)..
Assess Acceptability	We will consider the intervention to be acceptable if more than 50% of the patients approached agree to receive at least the first session of exercise counseling.	Acceptability will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00005664

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No