Prostate Cancer
Conditions
Keywords
Prescribed Physical Training, Exercise Program, Systemic and Organ Specific Prognostic Markers in Prostate Cancer
Brief summary
This research is being done to assess the impact of a supervised and structured strength and conditioning program on cardiac remodeling in participants with prostate cancer undergoing treatment with external beam radiation therapy and at least 6 months of Gonadotropin-releasing hormone (GnRH) therapy.
Detailed description
This study is designed to determine the impact of a strength and conditioning program on cardiac remodeling in participants with prostate cancer undergoing treatment with external beam radiation therapy and at least 6 months of Gonadotropin-releasing hormone (GnRH) therapy. In this study the participants will complete an exercise program that includes structured strength and conditioning programs which may include weightlifting, running, cycling, and stretching. During the research study participants will have data collected and blood samples taken which will be used to evaluate the prevention and reduction of potential harms induced by prostate cancer treatment. Participants will be in this research for 7 months which includes 6-months of the exercise intervention along with 1-month post-intervention activities. It is expected that about 20 people will take part in this research study.
Interventions
OTHERExercise
Supervised and structured strength and conditioning program
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have histologically or cytologically confirmed adenocarcinoma of the prostate * Have not received GnRH agonist or antagonist within the last 12 months * Planned for initiation of a GnRH agonist or antagonist or bilateral orchiectomy with an intended treatment duration of ≥ 6 months * Planned for initiation of radiation therapy to the prostate. * ECOG performance status of 0 or 1 * Ability to understand and the willingness to sign a written informed consent document * Baseline serum total testosterone level \> 230 ng/dL (the accepted threshold for testosterone supplementation) * Speak English -\>18 years of age
Exclusion criteria
* Has a known medical condition that makes the subject unable to participate in exercise testing (e.g. unrevascularized coronary artery disease, moderate/severe osteoarthritis, prior stroke, or other conditions) * Receiving or planned to receive other cancer therapy not included in Eligibility Criterion 3.1.3 (other than an antiandrogen during the first month of therapy) * The following populations will not be considered for inclusion on this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythrocyte sedimentation rate (mm/hr) | Time Frame: At the start of the exercise program for up to 1 month after exercise program. | Erythrocyte sedimentation rate (mm/hr) measured by blood draw |
| Neutrophil lymphocyte ratio (ratio) | Time Frame: At the start of the exercise program for up to 1 month after exercise program. | Neutrophil lymphocyte ratio (ratio) as measured from blood draw values |
| Systemic immune-inflammation index (SII) | Time Frame: At the start of the exercise program for up to 1 month after exercise program. | Systemic immune-inflammation index (SII) as derived from blood draw values |
| Hand grip strength (kg) | Time Frame: At the start of the exercise program for up to 1 month after exercise program. | Hand grip strength (kg) measured by dynamometer |
| Timed up and go test (seconds) | Time Frame: At the start of the exercise program for up to 1 month after exercise program. | Timed up and go test (seconds) measured by stopwatch during exercise testing. |
| Fatigue and health related quality of life (SF-36 questionnaire) | Time Frame: At the start of the exercise program for up to 1 month after exercise program. | Fatigue and health related quality of life (SF-36 questionnaire) measured by standardized patient questionnaire. |
| Blood pressure, systolic and diastolic (mmHg) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Blood pressure, systolic and diastolic (mmHg) as measured at Cardiopulmonary Exercise Testing |
| VO2max (mL/kg/min) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | VO2max (mL/kg/min) as measured on Cardiopulmonary Exercise Testing |
| C-reactive protein (mg/L) | Time Frame: At the start of the exercise program for up to 1 month after exercise program. | C-reactive protein (mg/L) measured by blood draw |
| Left Ventricular Ejection Fraction | At the start of the exercise program for up to 6 month after exercise program. | Left ventricular ejection fraction (%) as measured by echocardiogram |
| Left Ventricular Mass | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Left ventricular mass (g) as measured by echocardiogram |
| Left Ventricular Mass Index (g/m2) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Left ventricular mass index (g/m2) as measured by echocardiogram |
| Posterior cardiac wall thickness (mm) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Posterior cardiac wall thickness (mm) as measured by echocardiogram. |
| Relative cardiac wall thickness (ratio) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Relative cardiac wall thickness (ratio) as measured by echocardiogram |
| Left ventricular end-diastolic and end-systolic dimension (mm) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Left ventricular end-diastolic and end-systolic dimension (mm) as measured by echocardiogram. |
| Cardiac output (L/min) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Cardiac output (L/min) as measured by echocardiogram. |
| Heart rate (bpm) | Time Frame: At the start of the exercise program for up to 6 month after exercise program. | Heart rate (bpm) as measured by Cardiopulmonary Exercise Testing |
Countries
United States
Contacts
CONTACTPeter J. Lee, MD, PhD
PRINCIPAL_INVESTIGATORPeter Lee, MD, PhD
Massachusetts General Hospital
Outcome results
None listed