Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Malignant Neoplasm of Prostate

Treatments: Behavioral: Exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04556045

CASE8821

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Radiation Therapy + Exercise Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise therapy

Radiation Therapy

No Intervention group

Description:

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.