Exercise Therapy in Radiation Therapy (EXERT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of Treatment- Emergent Adverse Events
研究概览
简要总结
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.
详细描述
Study Objectives and Endpoints:
Aim 1. To determine the acceptability, feasibility, and safety of an exercise intervention among cancer patients receiving radiation therapy. The investigators anticipate that >25% of approached patients will consent to the protocol; >33% of eligible radiation therapy patients who consent will perform the exercise prescribed (based on the response rate from EnACT); and <25% of participants will experience a musculoskeletal impairment (without treatment alterations) and <5% will experience a musculoskeletal injury with symptoms lasting ≥ week or requiring medical attention. The investigators' approach will be to include patients receiving definitive RT; excluding patients at high risk for side effects from combination therapy, including fracture or cardiovascular events.
Aim 2. To discern the clinical outcomes of patients receiving RT+ET. The hypothesis is that adding ET to RT will improve patient reported outcomes and physical functioning. The investigators' approach will be to use standardized questionnaires and assessment tools: patient reported outcomes will be assessed using Common Terminology Criteria for Adverse Events - Patient Reported Outcomes (CTCAE-PROs), loaded onto tablets that patients use in the clinic. Questions will assess global PROs relevant to the ability to tolerate RT, including fatigue, pain, nausea, vomiting; and disease-site-specific PROs, including genitourinary/sexual symptoms for patients receiving pelvic RT. RT dose alterations will be documented. Scores will be compared pre- vs post- RT. The investigators will also use standardized measures already used in EnACT, including grip strength, 30-second chair stand, timed up-and-go, and 4-stage balance. Scores will be compared pre- vs post- RT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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 radiation therapy
- •Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for >1 month prior to start of radiation therapy may be eligible
- •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
- •Pregnant women
- •In-patient receiving radiation therapy for a radiation emergency (e.g. cord compression, SVC syndrome, brain metastases)
- •High risk of fracture or spine instability (Mirels score ≥7, SINS ≥7)
- •Children (the protocol will only include individuals 18 and older)
研究组 & 干预措施
Exercise
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).
干预措施: Exercise Therapy (Behavioral)
结局指标
主要结局
Incidence of Treatment- Emergent Adverse Events
时间窗: 1 year
Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event
Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached)
时间窗: 1 year
(number of patients agreeing to perform RT+ET)/(number approached)
Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
时间窗: 1 year
(number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
次要结局
- 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 Scored Patient-Generated Subjective Global Assessment(3 Months)
- Change in timed up and go(3 Months)
- change in quality of life measured via the Health Belief Scale(3 Months)
- change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire(3 Months)
- change in quality of life measured via the EORTC questionnaire(3 Months)
- change in grip strength(3 Months)
- change in quality of life measured via the ECHO EXERT survey(3 Months)
研究者
Kathleen Sturgeon
Assistant Professor
Milton S. Hershey Medical Center