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

Primary Purpose

Metastatic Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise therapy

About this trial

This is an interventional supportive care trial for Metastatic Prostate Cancer focused on measuring Exercise, Radiation, Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males ≥18 years of age receiving first palliative course of RT for metastatic prostate cancer
Patient receiving radiation dose of 20 Gray (Gy) in 5 fractions or stereotactic body radiation therapy (SBRT)
Patient must have received prior hormone therapy. Use of prior 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
Scheduled to receive radiation therapy at University Hospitals Cleveland Medical Center or University Hospitals Lake Health Center
Primary attending radiation oncologist approval

Exclusion Criteria:

Receiving radiation therapy at a location other than University Hospitals Cleveland Medical Center or University Hospitals Lake Health Center
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)

Sites / Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Radiation Therapy + Exercise Therapy

Radiation Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)

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.

Secondary Outcome Measures

Progression free survival

The hypothesis is that adding exercise therapy (ET) to radiation therapy (RT) will improve progression free survival, measured using RECIST criteria

Overall survival

The hypothesis is that adding exercise therapy (ET) to radiation therapy (RT) will improve overall survival, from the date of start of palliative radiotherapy until death.

Physical Function: Short Physical Performance Battery

Objectively-measured physical function will be assessed using the Short Physical Performance Battery (SPPB). The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands. Based on the time needed to complete the chair stands, a score is given. A summation of scores from all tests is taken, ranging from 0 -12. A higher score = Higher physical function.

Aerobic Capacity: Six Minute Walk Test

Objectively-measured physical function will be assessed using the Six Minute Walk Test (6MWT). Distance walked during 6 minutes (measured in meters) is measured. Longer distance = higher aerobic capacity.

Strength: Hand Grip Strength measured by the grip strength dynamometer test

Reliable and valid evaluation of hand strength can provide an objective index of general upper body strength. Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. The force is measured in kilograms and/or pounds and corresponds.

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)

QoL will be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0).

Evaluation of symptomatic toxicity in study participants using the Common Terminology Criteria for Adverse Events- Patient Reported Outcomes (CTCAE-PRO)

The PRO-CTCAE characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities that include pain, fatigue, nausea, and cutaneous side effects that can be meaningfully reported from the patient perspective. PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present) and evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic Adverse Event is assessed by 1-3 attributes. Criteria for grading on the CTCAE scale vary by toxicity. Grade 1: asymptomatic or mild symptoms not requiring intervention. Grade 2: moderate symptoms that interfere somewhat with daily function and where some intervention may be indicated. Grade 3: severe symptoms that interfere with daily activities or require more significant intervention. Grade 4: toxicity that is life-threatening, with urgent intervention indicated.

Godin Physical Activity Questionnaire

Physical activity behavior in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Godin Physical Activity Questionnaire. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula: Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light) Higher activity score = more active

Fatigue: Fatigue Symptom Inventory

The Fatigue Symptom Inventory (FSI) assesses the frequency and severity of fatigue as well as its perceived disruptiveness. Frequency is measured as the number of days in the past week (0-7) respondents felt fatigued as well as the percentage of each day on average they felt fatigued (0 = none, 10 = entire day).

Quantification of IL-1Ra in blood

A 2-4mL blood sample will be collected to determine participants levels of the biomarker IL-1Ra. Samples will be run via ELISA and concentrations will be reported as pg/mL.

Full Information

NCT ID

NCT04556045

First Posted

July 28, 2020

Last Updated

October 4, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04556045

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2024 (Anticipated)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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 metastatic cancer patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Prostate Cancer

Keywords

Exercise, Radiation, Prostate Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiation Therapy + Exercise Therapy

Arm Type

Experimental

Arm Description

Arm Title

Radiation Therapy

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise therapy

Intervention Description

The exercise therapy intervention will last 4 weeks. Each participant assigned to this intervention will receive a personalized ET regimen, including in-person, supervised exercise sessions; other activities to be followed at home. Participants will exercise between one and seven times per week depending on their tolerance to the treatment and exercise program.

Primary Outcome Measure Information:

Title

Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)

Description

Time Frame

At 1 month follow up

Secondary Outcome Measure Information:

Title

Progression free survival

Description

The hypothesis is that adding exercise therapy (ET) to radiation therapy (RT) will improve progression free survival, measured using RECIST criteria

Time Frame

Within 5 years

Title

Overall survival

Description

The hypothesis is that adding exercise therapy (ET) to radiation therapy (RT) will improve overall survival, from the date of start of palliative radiotherapy until death.

Time Frame

Within 5 years

Title

Physical Function: Short Physical Performance Battery

Description

Time Frame

At 1 month follow up

Title

Aerobic Capacity: Six Minute Walk Test

Description

Time Frame

At 1 month follow up

Title

Strength: Hand Grip Strength measured by the grip strength dynamometer test

Description

Time Frame

At 1 month follow up

Title

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)

Description

Time Frame

At 1 month follow up

Title

Evaluation of symptomatic toxicity in study participants using the Common Terminology Criteria for Adverse Events- Patient Reported Outcomes (CTCAE-PRO)

Description

Time Frame

At 1 month follow up

Title

Godin Physical Activity Questionnaire

Description

Time Frame

At 1 month follow up

Title

Fatigue: Fatigue Symptom Inventory

Description

Time Frame

At 1 month follow up

Title

Quantification of IL-1Ra in blood

Description

A 2-4mL blood sample will be collected to determine participants levels of the biomarker IL-1Ra. Samples will be run via ELISA and concentrations will be reported as pg/mL.

Time Frame

At 1 month follow up

Other Pre-specified Outcome Measures:

Title

Work Productivity and Activity Impairment Questionnaire

Description

The Work Productivity and Activity Impairment Questionnaire assesses the effect of patient's health problems on their ability to work and perform regular activities. Subjects self reports as "fill in blank" answers to questions and also as circling a number on a 10 point scale where 0 = Problem had no effect on my work and 10 = Problem completely prevented me from doing my daily activities.

Time Frame

At 1 month follow up

Title

Barriers to Exercise RM 5-FM

Description

Examines factors that have an impact on the development and implementation of and adherence to a personal physical activity plan. Questions are scored on a range of 0-3 where, Very Unlikely = 0 and Very Likely = 3. Barriers to physical activity fall into one or more of seven categories: lack of time, social influences, lack of energy, lack of willpower, fear of injury, lack of skill, and lack of resources. A score of 5 or above in any category shows that this is an important barrier to overcome.

Time Frame

At 1 month follow up

Title

Exploratory pro-inflammatory (IL-1B, IL-6, TNF-α, IL-8, IL-15, CRP) and anti-inflammatory (IL-10) markers

Description

A 2-4mL blood sample will be collected to determine participants levels of pro- and anti-inflammatory biomarkers.

Time Frame

At 1 month follow up

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males ≥18 years of age receiving first palliative course of RT for metastatic prostate cancer Patient receiving radiation dose of 20 Gray (Gy) in 5 fractions or stereotactic body radiation therapy (SBRT) Patient must have received prior hormone therapy. Use of prior 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 Scheduled to receive radiation therapy at University Hospitals Cleveland Medical Center or University Hospitals Lake Health Center Primary attending radiation oncologist approval Exclusion Criteria: Receiving radiation therapy at a location other than University Hospitals Cleveland Medical Center or University Hospitals Lake Health Center 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicholas G Zaorsky, MD, MS

Phone

1-800-641-2422

Nicholas.Zaorsky@uhhospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Zaorsky, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Plan to share all collected data relevant to results in publication.

Learn more about this trial

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

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