Exercise in All ChemoTherapy (EnACT)

June 21, 2019 updated by: Kathryn Schmitz, Milton S. Hershey Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Exercise intervention
Behavioral: Exercise Intervention
Exercise intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess Feasibility
Time Frame: Feasibility will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare changes in pain, physical function, nausea, vomiting, arthralgias, chemotherapy alterations (dose delays and alterations).
Time Frame: 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).
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.
Time Frame: Surveys will be provided to clinicians at the completion of the study (up to 38 months)
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
Time Frame: A standardized survey for assessing injuries will be used and administered at the end of the patients chemotherapy (average of 5 months)..
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
Time Frame: Acceptability will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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