Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)
研究概览
简要总结
This study is being done to determine if patients receiving personalized exercise therapy (versus those who do not receive personalized exercise therapy) have improved quality of life and physical functioning after completing their radiation therapy. Second, the study is being done to find if the quality of life changes during therapy correlate with measurements of inflammation in the blood. Third, the study is being done to see if adding exercise therapy to radiation therapy will improve survival.
详细描述
In 2018, 30,000 patients were diagnosed metastatic prostate cancer in the US. Short-course radiation therapy (RT) is a mainstay of treatment for symptomatic metastases, and it stimulates an immune response against the tumor. However, RT also decreases systemic interleukin-1 receptor antagonist (IL-1Ra), placing the body in a pro-inflammatory state, and increasing fatigue and reducing quality of life (QOL). Fatigue and QOL are surrogates of the limited 2-20 month survival time. If fatigue and quality of life are improved, then toxicity and survival will follow.
Our long-term goal is to identify the potential for exercise therapy (ET) to improve RT treatment toxicities and outcomes among men diagnosed with metastatic prostate cancer metastatic to distant sites or regional lymph nodes. The mechanistic hypothesis is that adding ET training to RT decreases long-term systemic inflammation, mitigating toxicity thereby widening the therapeutic window.
Objective 1. Quantify the potential of Exercise Therapy (ET) to mitigate Radiation Treatment (RT) toxicities and physical function decline. The hypothesis is that ET mitigates patient-reported quality of life (QOL) and toxicities of RT. Our approach will be to use standardized questionnaires and assessment tools to assess QOL and physical function.
Objective 2. Characterize the immunologic mechanism by which ET mitigates RT toxicity. The hypothesis is that ET mitigates the toxicity of RT (measured in objective 1) by increasing serum interleukin-1Ra (IL-1Ra).
Objective 3. Evaluate the ability of ET to improve survival. Since physical function is a surrogate of survival, the hypothesis is that adding ET to RT will improve overall survival, measured from the date of start of radiotherapy until death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must have lymph node positive or metastatic disease consistent with prostate cancer
- •Males ≥18 years of age receiving RT
- •Patient receiving 5 fractions or stereotactic body radiation therapy (SBRT)
- •Patient may have received prior hormone therapy. Prior or current use of chemotherapy agents is allowed, but not necessary.
- •Fluent in written and spoken English
- •Must be able to provide and understand informed consent
- •Must have an ECOG Performance Status (PS) of ≤ 3
- •Primary attending radiation oncologist approval
排除标准
- •Performing > 90 minutes/week of exercise therapy prior at time of enrollment
- •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 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 complete study requirements
- •In-patient receiving radiation therapy for a radiation emergency (e.g. cord compression, Superior vena cava (SVC) syndrome, brain metastases)
- •High risk of fracture or spine instability (Mirels score ≥7, SINS ≥7)
- •Children (the protocol will only include men age 18 and older)
研究组 & 干预措施
Radiation Therapy + Exercise Therapy
This group will receive exercise intervention in addition to their standard of care radiation treatment. At the baseline visit, they will meet with the certified exercise trainer (CET) and will be provided with a personalized exercise prescription and log to record what they do in between daily radiation treatment visits. The participant will also undergo an in-person exercise session prior to radiation therapy, which will take place either on the same day that the physical function tests are preformed or on a separate day. Participants will exercise between 1 and 7 times/week depending on the patient's tolerance to the exercise prescription. The CET will meet with the participant at every radiation treatment visit for an exercise counseling check-in. After five radiation treatments, the CET will follow-up with the participants via phone call once per week for 4 weeks during the follow-up period.
干预措施: Exercise therapy (Behavioral)
Radiation Therapy
The observational group will continue with their usual standard of care of radiation therapy. The study team will provide patients with an educational pamphlet at the end of their baseline visit. They will also be provided with a self-directed exercise program framework. Additionally, the participant's medical record will be reviewed for serious adverse events during their time on study. Baseline and final measurements will be obtained.
结局指标
主要结局
Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)
时间窗: At 12 week follow up
Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1. 2 short form is a 10-item instrument representing multiple domains. Scores are assigned for both Global Physical Health component and Global Mental Health component. The response scores range from 1-5, where 1 = always and 5 = Never. A higher score from responses indicate better health.
次要结局
- Aerobic Capacity: Six Minute Walk Test(At 1 month follow up)
- Strength: Hand Grip Strength measured by the grip strength dynamometer test(At 1 month follow up)
- Progression free survival(Within 5 years)
- Physical Function: Short Physical Performance Battery(At 1 month follow up)
- Godin Physical Activity Questionnaire(At 1 month follow up)
- Quantification of IL-1Ra in blood(At 1 month follow up)
- Overall survival(Within 5 years)
- Fatigue: Fatigue Symptom Inventory(At 1 month follow up)
- Evaluation of symptomatic toxicity in study participants using the Common Terminology Criteria for Adverse Events- Patient Reported Outcomes (CTCAE-PRO)(At 1 month follow up)
- Health-related Quality of Life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0)(At 1 month follow up)