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| ID | Type | Description | Link |
|---|---|---|---|
| RSG-17-050-01-NEC | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss and Weight Maintenance | Experimental | Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery. |
|
| Control | Active Comparator | Participants will receive a standardized educational flyer about a healthy diet and exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss Program | Behavioral | Program involves one-on-one coaching, diet meal plan, and physical activity plan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors | Impact will be measured by changes in specific blood immune biomarker monocytic myeloid-derived suppressor cells (mMDSCs). The absolute number of cell counts were calculated using the lymphocyte count abstracted from the complete blood count with differential. | Change from Baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors | Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio. | Change from Baseline to Month 6 |
| Change in Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Hamilton-Reeves, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38299570 | Derived | Bechtel MD, Michel C, Srinivasan P, Chalise P, Parker WP, Mirza M, Thrasher B, Gibbs HD, DiGiovanni J, Hamilton-Reeves J. Impact of Weight Management on Obesity-Driven Biomarkers of Prostate Cancer Progression. J Urol. 2024 Apr;211(4):552-562. doi: 10.1097/JU.0000000000003849. Epub 2024 Feb 1. |
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Upon enrollment, participants were randomized to either the intervention or active control arms.
Participant enrollment took place from November 2017 to August 2020 at The University of Kansas Health System. Participants were recruited from the Department of Urology medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Weight Loss and Weight Maintenance | Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery. Weight Loss Program: Program involves one-on-one coaching, diet meal plan, and physical activity plan. Weight Maintenance Program: Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring. |
| FG001 | Control | Participants will receive a standardized educational flyer about a healthy diet and exercise. Standardized educational flyer: The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Weight Loss and Weight Maintenance | Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery. Weight Loss Program: Program involves one-on-one coaching, diet meal plan, and physical activity plan. Weight Maintenance Program: Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors | Impact will be measured by changes in specific blood immune biomarker monocytic myeloid-derived suppressor cells (mMDSCs). The absolute number of cell counts were calculated using the lymphocyte count abstracted from the complete blood count with differential. | Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control). | Posted | Mean | Standard Deviation | count of cells | Change from Baseline to Month 6 |
|
4-16 weeks prior to surgery and 6 months after surgery. At most, 10 months.
Adverse Events were not assessed for the control group since they did not follow the study intervention. The control group received educational materials and followed standard of care.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Weight Loss and Weight Maintenance | Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery. Weight Loss Program: Program involves one-on-one coaching, diet meal plan, and physical activity plan. Weight Maintenance Program: Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE v.4.0 | Systematic Assessment |
This randomized controlled trial could not be blinded to participants due to the nature of the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Hamilton-Reeves | University of Kansas Medical Center | 913-588-7650 | jhamilton-reeves@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2020 | Oct 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 3, 2019 | Oct 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061217 | Weight Reduction Programs |
| ID | Term |
|---|---|
| D006293 | Health Promotion |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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| Standardized educational flyer | Behavioral | The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants. |
|
| Weight Maintenance Program | Behavioral | Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring. |
|
Body weight will be measured at participant study visits.
| Change from Baseline to Month 6 |
| Change in Body Composition | Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA). Change in percent body fat will be analyzed between groups from baseline to study end. | Change from Baseline to Study End |
| Change in Quality of Life | Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life. | Change from Baseline to Month 6 |
| BG001 | Control | Participants will receive a standardized educational flyer about a healthy diet and exercise. Standardized educational flyer: The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest Education Level | Count of Participants | Participants |
|
| Rural-Urban Commuting Area (RUCA) Codes | RUCA codes are a census tract-based classification that uses standard census measures of population density, levels of urbanization and daily commuting patterns. Codes range from 1 (highly urban) to 10 (highly rural). | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Preoperative Erectile Dysfunction | Count of Participants | Participants |
|
| Prostate Specific Antigen (PSA) | Mean | Standard Deviation | ng/mL |
|
| Gleason score | A Gleason score is a grading system used to describe prostate cancer and determine its aggressiveness. Gleason scores range from 2-10. Pathologists rarely assign scores 2-5. Gleason scores assigned will range from 6 to 10, with 6 being low grade, 7 intermediate grade, and a score of 8 to 10 is high grade cancer. | Mean | Standard Deviation | units on a scale |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG001 | Control | Participants will receive a standardized educational flyer about a healthy diet and exercise. Standardized educational flyer: The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants. |
|
|
|
| Secondary | Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors | Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio. | Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control). | Posted | Mean | Standard Deviation | leptin/adiponectin ratio | Change from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Weight | Body weight will be measured at participant study visits. | Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control). | Posted | Mean | Standard Deviation | weight in kilograms | Change from Baseline to Month 6 |
|
|
|
|
| Secondary | Change in Body Composition | Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA). Change in percent body fat will be analyzed between groups from baseline to study end. | Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control). | Posted | Mean | Standard Deviation | percentage of body fat | Change from Baseline to Study End |
|
|
|
|
| Secondary | Change in Quality of Life | Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life. | Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control). | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Month 6 |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 7 |
| 20 |
| Bloating | Gastrointestinal disorders | CTCAE v.4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v.4.0 | Systematic Assessment |
|
| Muscle pain or strain | Musculoskeletal and connective tissue disorders | CTCAE v.4.0 | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D005159 |
| Health Care Facilities Workforce and Services |
| 1 week prior to surgery leptin/adiponectin ratio |
|
|
| 6 months after surgery leptin/adiponectin ratio |
|
|
| 1 week prior to surgery body weight (kg) |
|
|
| 6 months after surgery body weight (kg) |
|
|
| 1 week prior to surgery body fat % |
|
|
| 6 months after surgery body fat % |
|
|
| General Health Quality of Life at Study End |
|
| 0.04 |
| Superiority |