Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20857 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2023-07008 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance.
The name of the study intervention involved in this study is:
Aerobic high-intensity interval training (HIIT) (training exercise intervention)
This research study is a randomized controlled study for a home-based, virtually supervised, aerobic exercise intervention for men with prostate cancer at high-risk of progression undergoing active surveillance. There is evidence that exercise may suppress cancer progression, but the evidence is preliminary.
Participants will be randomized into one of two treatment groups: Group A: Aerobic high-intensity interval training (HIIT) versus Group B: Waitlist Control. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, study treatment visits, survey questionnaires, blood tests, and follow-up visits.
Participation in this research study is expected to last about 14 weeks.
It is expected that about 68 people will take part in this research study.
The Prostate Cancer Foundation is providing funding for this research study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: HIIT Exercise Program | Experimental | Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:
|
|
| Group B: Waitlist Control | Experimental | Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Interval Training Exercise Program | Behavioral | Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate-Specific Antigen (PSA) Level | The primary outcome is the between-group difference in prostate-specific antigen (PSA) levels post-intervention. Analysis of covariance will be used to detect the difference adjusting for baseline values of the outcome and other covariates. | Baseline (Week 1) and post-intervention (Week 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate-Specific Antigen (PSA) Velocity | PSA velocity will be calculated following the PSA Working Group Guidelines, using the three most recent PSA values obtained from the medical chart with the first and last values being at least three months apart. The formula was based on the natural logarithm of 2 (0.693) divided by the slope obtained from fitting a linear regression of the natural log of PSA. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Woo Kang, PhD | Contact | 206-667-5188 | dkang@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Dong-Woo Kang, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Completed | Boston | Massachusetts | 02215 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Principal investigator blinded to block size
|
| High-Intensity Interval Training Exercise Program | Behavioral | (Optionally) Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor. |
|
| Baseline (Week 1) and post-intervention (Week 14) |
| Prostate-Specific Antigen (PSA) Doubling Time | PSA doubling time will be calculated following the PSA Working Group Guidelines, using the three most recent PSA values obtained from the medical chart with the first and last values being at least three months apart. PSA velocity will be used to calculate the number of years that PSA levels become doubles, where the longer the time the better the prognosis. | Baseline (Week 1) and post-intervention (Week 14) |
| Proliferation of LNCaP Prostate Cancer Cell Line | LNCaP cells are androgen-sensitive human prostate adenocarcinoma cells. LNCaP cells will be grown in vitro and their growth rate will be measured by counting the number of cells over time. | Baseline (Week 1) and post-intervention (Week 14) |
| Cardiorespiratory Fitness | Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal or submaximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 15-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms. | Baseline (Week 1) and post-intervention (Week 14) |
| Muscular Strength | Muscular strength will be measured as 1-repetition maximum (RM) (i.e., the greatest resistance that can be moved through the full range of motion), which has been the standard for strength assessments. 1-RM values will be estimated from 10-RM using validated equations on 2 exercises (chest press and leg press). | Baseline (Week 1) and post-intervention (Week 14) |
| Short Physical Performance Battery (SPPB) | Physical function will be assessed by the Short Physical Performance Battery (SPPB), which includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded. | Baseline (Week 1) and post-intervention (Week 14) |
| Health-Related Quality of Life | The European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire-C30 (EORTC-QLQ C30) will assess health-related quality of life, consisting of subscales including functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures. The score ranges from 0 to 100 and a higher value indicates a better quality of life. | Baseline (Week 1) and post-intervention (Week 14) |
| Prostate Cancer-Specific Anxiety | Assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), an 18-item questionnaire with a 4-point Likert-type scale asking how frequently certain "comments made by men about prostate cancer" were true of the respondent. Each item is scored from 0 to 4 with anchors ranging from "Not at all" to "Often." | Baseline (Week 1) and post-intervention (Week 14) |
| Fear of Cancer Progression Assessment | The Fear of Cancer Recurrence Inventory (FCRI) is a well-established scale for in-depth assessment of FCR in research. The short form of this measure (FCRI-SF), consisting of 9 items, has been used as a tool to screen for clinical levels of fear of cancer recurrence (FCR). The FCRI-SF is often used to identify potential cases of clinically significant FCR. | Baseline (Week 1) and post-intervention (Week 14) |
| Sleep Quality | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The seven components are then summed to obtain a global score ranging from 0-21 points. | Baseline (Week 1) and post-intervention (Week 14) |
| Brigham and Women's Hospital |
| Completed |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Completed | Boston | Massachusetts | 02215 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided