Trial Outcomes & Findings for Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy (NCT NCT03261271)
NCT ID: NCT03261271
Last Updated: 2025-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Change from Baseline to Month 6
Results posted on
2025-04-13
Participant Flow
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.
Upon enrollment, participants were randomized to either the intervention or active control arms.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Treatment changed after surgery. Participants were removed from the study.
|
1
|
1
|
Baseline Characteristics
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Weight Loss and Weight Maintenance
n=20 Participants
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.
|
Control
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.25 years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
60.80 years
STANDARD_DEVIATION 5.66 • n=7 Participants
|
60.03 years
STANDARD_DEVIATION 5.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Highest Education Level
High School/GED
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Highest Education Level
Some College/Associate's
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Highest Education Level
Bachelor's
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Highest Education Level
Master's
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Highest Education Level
Doctoral
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Highest Education Level
Not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) Codes
RUCA Code 1
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) Codes
RUCA Code 2
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) Codes
RUCA Code 4
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) Codes
RUCA Code 7
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) Codes
RUCA Code 10
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Smoking Status
Former Smoker
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Smoking Status
Never Smoked
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Preoperative Erectile Dysfunction
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Prostate Specific Antigen (PSA)
|
7.96 ng/mL
STANDARD_DEVIATION 5.76 • n=5 Participants
|
8.31 ng/mL
STANDARD_DEVIATION 6.09 • n=7 Participants
|
8.14 ng/mL
STANDARD_DEVIATION 5.85 • n=5 Participants
|
|
Gleason score
|
7.05 units on a scale
STANDARD_DEVIATION 0.76 • n=5 Participants
|
7.05 units on a scale
STANDARD_DEVIATION 0.22 • n=7 Participants
|
7.05 units on a scale
STANDARD_DEVIATION 0.55 • n=5 Participants
|
|
Weight
|
106.94 kg
STANDARD_DEVIATION 17.15 • n=5 Participants
|
101.54 kg
STANDARD_DEVIATION 10.42 • n=7 Participants
|
104.24 kg
STANDARD_DEVIATION 14.27 • n=5 Participants
|
|
Height
|
177.38 cm
STANDARD_DEVIATION 6.60 • n=5 Participants
|
176.55 cm
STANDARD_DEVIATION 4.45 • n=7 Participants
|
176.96 cm
STANDARD_DEVIATION 5.57 • n=5 Participants
|
|
BMI
|
33.95 kg/m2
STANDARD_DEVIATION 4.90 • n=5 Participants
|
32.59 kg/m2
STANDARD_DEVIATION 3.29 • n=7 Participants
|
33.27 kg/m2
STANDARD_DEVIATION 4.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Month 6Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
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.
Outcome measures
| Measure |
Weight Loss and Weight Maintenance
n=20 Participants
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.
|
Control
n=20 Participants
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.
|
|---|---|---|
|
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
Baseline mMDSC count
|
19.29 count of cells
Standard Deviation 26.72
|
17.37 count of cells
Standard Deviation 18.96
|
|
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
1 week prior to surgery mMDSC count
|
17.68 count of cells
Standard Deviation 21.14
|
12.76 count of cells
Standard Deviation 15.64
|
|
Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors
6 months after surgery mMDSC count
|
40.52 count of cells
Standard Deviation 44.87
|
32.91 count of cells
Standard Deviation 36.38
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio.
Outcome measures
| Measure |
Weight Loss and Weight Maintenance
n=20 Participants
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.
|
Control
n=20 Participants
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.
|
|---|---|---|
|
Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors
Baseline leptin/adiponectin ratio
|
0.28 leptin/adiponectin ratio
Standard Deviation 0.29
|
0.28 leptin/adiponectin ratio
Standard Deviation 0.27
|
|
Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors
1 week prior to surgery leptin/adiponectin ratio
|
0.16 leptin/adiponectin ratio
Standard Deviation 0.21
|
0.29 leptin/adiponectin ratio
Standard Deviation 0.22
|
|
Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors
6 months after surgery leptin/adiponectin ratio
|
0.11 leptin/adiponectin ratio
Standard Deviation 0.14
|
0.25 leptin/adiponectin ratio
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
Body weight will be measured at participant study visits.
Outcome measures
| Measure |
Weight Loss and Weight Maintenance
n=20 Participants
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.
|
Control
n=20 Participants
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.
|
|---|---|---|
|
Change in Weight
1 week prior to surgery body weight (kg)
|
101.1 weight in kilograms
Standard Deviation 16.5
|
100.6 weight in kilograms
Standard Deviation 11.1
|
|
Change in Weight
6 months after surgery body weight (kg)
|
95.8 weight in kilograms
Standard Deviation 17.5
|
99.8 weight in kilograms
Standard Deviation 11.1
|
|
Change in Weight
Baseline body weight (kg)
|
106.9 weight in kilograms
Standard Deviation 17.2
|
101.5 weight in kilograms
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Change from Baseline to Study EndPopulation: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
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.
Outcome measures
| Measure |
Weight Loss and Weight Maintenance
n=20 Participants
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.
|
Control
n=20 Participants
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.
|
|---|---|---|
|
Change in Body Composition
Baseline body fat %
|
39.2 percentage of body fat
Standard Deviation 4.9
|
37.6 percentage of body fat
Standard Deviation 4.3
|
|
Change in Body Composition
1 week prior to surgery body fat %
|
37.1 percentage of body fat
Standard Deviation 5.4
|
37.4 percentage of body fat
Standard Deviation 4.8
|
|
Change in Body Composition
6 months after surgery body fat %
|
34.0 percentage of body fat
Standard Deviation 7.6
|
36.7 percentage of body fat
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
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.
Outcome measures
| Measure |
Weight Loss and Weight Maintenance
n=20 Participants
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.
|
Control
n=20 Participants
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.
|
|---|---|---|
|
Change in Quality of Life
General Health Quality of Life at Baseline
|
47.8 units on a scale
Standard Deviation 7.0
|
48.0 units on a scale
Standard Deviation 7.8
|
|
Change in Quality of Life
General Health Quality of Life at Pre-Surgery
|
52.5 units on a scale
Standard Deviation 6.0
|
48.6 units on a scale
Standard Deviation 8.5
|
|
Change in Quality of Life
General Health Quality of Life at Study End
|
52.0 units on a scale
Standard Deviation 8.6
|
47.7 units on a scale
Standard Deviation 8.9
|
Adverse Events
Weight Loss and Weight Maintenance
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Weight Loss and Weight Maintenance
n=20 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Bloating
|
5.0%
1/20 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain or strain
|
20.0%
4/20 • Number of events 4 • 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.
|
Additional Information
Dr. Jill Hamilton-Reeves
University of Kansas Medical Center
Phone: 913-588-7650
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place