Clinical trial NCT03461471: Exercise in All ChemoTherapy
Official title: Exercise in All ChemoTherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy
Exercise
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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)

Primary outcomes:
measure: Assess Feasibility
timeFrame: Feasibility will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).
Secondary outcomes:
measure: Compare changes in pain, physical function, nausea, vomiting, arthralgias, chemotherapy alterations (dose delays and alterations).
timeFrame: 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).
measure: 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.
timeFrame: Surveys will be provided to clinicians at the completion of the study (up to 38 months)
measure: Assessing safety through number of patients with injuries related to the intervention
timeFrame: A standardized survey for assessing injuries will be used and administered at the end of the patients chemotherapy (average of 5 months)..
measure: Assess Acceptability
timeFrame: Acceptability will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Kathryn Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: