Exercise Therapy in Radiation Therapy

NCT03905356 | Completed

• 1 other identifier: STUDY00010618
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate exercise therapy as a method for potentially improving radiation therapy treatment toxicities for metastatic cancer patients receiving radiation therapy.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (3)

• Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached)

  (number of patients agreeing to perform RT+ET)/(number approached)

  1 year

• Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)

  (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)

  1 year

• Incidence of Treatment- Emergent Adverse Events

  Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event

  1 year

Secondary Outcomes (9)

• Change in timed up and go

  3 Months

• change in grip strength

  3 Months

• change in quality of life measured via the Godin Physical Activity Questionnaire

  3 Months

• change in quality of life measured via the Barriers to Exercise RM 5-FM survey

  3 Months

• change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire

  3 Months

Study Arms (1)

Exercise

EXPERIMENTAL

The exercise intervention will utilize the "Moving Through Cancer: A Guide to Exercise for Cancer Survivors" framework. A certified cancer exercise physiologist will work through this guide at radiation therapy visits, with at least 1 visit per week, per the study schema. The cancer exercise physiologist will teach participants proper: warm ups, use of equipment, exercise form, modes of activity, intensity of exercise, flexibility exercises, and cool down. The cancer exercise physiologist will tailor the instruction to convey special considerations for exercise based on treatment and cancer type. The patient will perform supervised exercise in the Exercise Medicine Unit under the guidance of the cancer exercise specialist. The exercise done will be educational in nature (i.e. learning about proper walking form, proper intensity for a warmup/cool down, proper techniques for resistance exercises).

Behavioral: Exercise Therapy

Interventions

Exercise Therapy BEHAVIORAL

Certified exercise oncology specialists will personalize, prescribe, and guide ET, including twice weekly resistance training and walking, performed at home, with supervision in the Exercise Medicine Unit. The cancer exercise physiologist will teach participants proper warm ups, use of equipment, exercise form, modes of activity, intensity of exercise, flexibility exercises, and cool down. In addition, patients will be instructed to exercise on their own, at home, according to the instructions from the cancer exercise specialist.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 metastatic disease
• Cancer patients (stage 1-4)
• Treatment to primary site or metastatic disease
• Scheduled to receive radiation therapy at Penn State Cancer Institute
• Absence of absolute contraindications for exercise according to the American Heart Association (see below)
• Primary attending oncologist approval
• Receiving treatment as an outpatient

You may not qualify if:

• Receiving radiation therapy at a location other than Penn State Cancer Institute
• Not fluent in written and spoken English
• Evidence in the medical record of an absolute contraindication for exercise
• Performing \> 90 minutes/week of physical activity at the time of initial evaluation
• 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 radiation therapy
• Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for \>1 month prior to start of radiation therapy 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Kathleen Sturgeon, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 5, 2019
• Study Start: February 12, 2020
• Primary Completion: January 26, 2022
• Study Completion: January 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)