Malignant Neoplasm of Prostate
Conditions
Keywords
Exercise, Radiation, Prostate Cancer
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 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.
Interventions
BEHAVIORALExercise therapy
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.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | Within 5 years | The hypothesis is that adding exercise therapy (ET) to radiation therapy (RT) will improve progression free survival, measured using RECIST criteria |
| Overall survival | Within 5 years | 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 | At 1 month follow up | 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 | At 1 month follow up | 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 | At 1 month follow up | 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) | At 1 month follow up | 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) | At 1 month follow up | 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 | At 1 month follow up | 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 | At 1 month follow up | 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 | At 1 month follow up | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAngela Jia, MD, PhD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Outcome results
None listed