Obesity, Prostate Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALWeight Loss Program
Program involves one-on-one coaching, diet meal plan, and physical activity plan.
BEHAVIORALStandardized educational flyer
The American Institute for Cancer Research handout Nutrition and the Cancer Survivor will be provided to participants.
BEHAVIORALWeight Maintenance Program
Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
Sponsors
American Cancer Society, Inc.
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2) * Body Mass Index (BMI) 25-45 kg/m2 * Has internet access
Exclusion criteria
* History of 5 alpha reductase inhibitors prior 3 months * History of radiation therapy for cancer treatment * Taking active cancer treatment * Undergoing salvage therapy * Castration-resistant PCa * Evidence of metastasis * Evidence of biochemical recurrence * High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors | Change from Baseline to Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors | Change from Baseline to Month 6 | Impact will be measured by changes in specific blood biomarker leptin/adiponectin ratio. |
| Change in Weight | Change from Baseline to Month 6 | Body weight will be measured at participant study visits. |
| Change in Body Composition | Change from Baseline to Study End | 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 in Quality of Life | Change from Baseline to Month 6 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Upon enrollment, participants were randomized to either the intervention or active control arms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Treatment changed after surgery. Participants were removed from the study. | 1 | 1 |
Baseline characteristics
| Characteristic | Weight Loss and Weight Maintenance | Control | Total |
|---|---|---|---|
| Age, Continuous | 59.25 years STANDARD_DEVIATION 5.86 | 60.80 years STANDARD_DEVIATION 5.66 | 60.03 years STANDARD_DEVIATION 5.74 |
| BMI | 33.95 kg/m2 STANDARD_DEVIATION 4.9 | 32.59 kg/m2 STANDARD_DEVIATION 3.29 | 33.27 kg/m2 STANDARD_DEVIATION 4.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 19 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gleason score | 7.05 units on a scale STANDARD_DEVIATION 0.76 | 7.05 units on a scale STANDARD_DEVIATION 0.22 | 7.05 units on a scale STANDARD_DEVIATION 0.55 |
| Height | 177.38 cm STANDARD_DEVIATION 6.6 | 176.55 cm STANDARD_DEVIATION 4.45 | 176.96 cm STANDARD_DEVIATION 5.57 |
| Highest Education Level Bachelor's | 4 Participants | 7 Participants | 11 Participants |
| Highest Education Level Doctoral | 0 Participants | 0 Participants | 0 Participants |
| Highest Education Level High School/GED | 2 Participants | 3 Participants | 5 Participants |
| Highest Education Level Master's | 4 Participants | 2 Participants | 6 Participants |
| Highest Education Level Not reported | 0 Participants | 1 Participants | 1 Participants |
| Highest Education Level Some College/Associate's | 10 Participants | 7 Participants | 17 Participants |
| Preoperative Erectile Dysfunction | 9 Participants | 10 Participants | 19 Participants |
| Prostate Specific Antigen (PSA) | 7.96 ng/mL STANDARD_DEVIATION 5.76 | 8.31 ng/mL STANDARD_DEVIATION 6.09 | 8.14 ng/mL STANDARD_DEVIATION 5.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 18 Participants | 36 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Rural-Urban Commuting Area (RUCA) Codes RUCA Code 1 | 12 Participants | 13 Participants | 25 Participants |
| Rural-Urban Commuting Area (RUCA) Codes RUCA Code 10 | 0 Participants | 2 Participants | 2 Participants |
| Rural-Urban Commuting Area (RUCA) Codes RUCA Code 2 | 7 Participants | 2 Participants | 9 Participants |
| Rural-Urban Commuting Area (RUCA) Codes RUCA Code 4 | 0 Participants | 1 Participants | 1 Participants |
| Rural-Urban Commuting Area (RUCA) Codes RUCA Code 7 | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
| Smoking Status Current Smoker | 2 Participants | 1 Participants | 3 Participants |
| Smoking Status Former Smoker | 8 Participants | 10 Participants | 18 Participants |
| Smoking Status Never Smoked | 10 Participants | 9 Participants | 19 Participants |
| Weight | 106.94 kg STANDARD_DEVIATION 17.15 | 101.54 kg STANDARD_DEVIATION 10.42 | 104.24 kg STANDARD_DEVIATION 14.27 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Change from Baseline to Month 6
Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss and Weight Maintenance | 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 |
| Weight Loss and Weight Maintenance | 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 |
| Weight Loss and Weight Maintenance | 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 |
| Control | Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors | Baseline mMDSC count | 17.37 count of cells | Standard Deviation 18.96 |
| Control | Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors | 1 week prior to surgery mMDSC count | 12.76 count of cells | Standard Deviation 15.64 |
| Control | Impact of Weight Loss Before and Weight Maintenance After Prostate Cancer (PCa) Surgery on Immunosuppressive Factors | 6 months after surgery mMDSC count | 32.91 count of cells | Standard Deviation 36.38 |
p-value: 0.6489Mixed Models Analysis
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.
Time frame: Change from Baseline to Study End
Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss and Weight Maintenance | Change in Body Composition | Baseline body fat % | 39.2 percentage of body fat | Standard Deviation 4.9 |
| Weight Loss and Weight Maintenance | Change in Body Composition | 1 week prior to surgery body fat % | 37.1 percentage of body fat | Standard Deviation 5.4 |
| Weight Loss and Weight Maintenance | Change in Body Composition | 6 months after surgery body fat % | 34.0 percentage of body fat | Standard Deviation 7.6 |
| Control | Change in Body Composition | Baseline body fat % | 37.6 percentage of body fat | Standard Deviation 4.3 |
| Control | Change in Body Composition | 1 week prior to surgery body fat % | 37.4 percentage of body fat | Standard Deviation 4.8 |
| Control | Change in Body Composition | 6 months after surgery body fat % | 36.7 percentage of body fat | Standard Deviation 4.2 |
p-value: <0.0001Mixed Models Analysis
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.
Time frame: Change from Baseline to Month 6
Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss and Weight Maintenance | Change in Quality of Life | General Health Quality of Life at Pre-Surgery | 52.5 units on a scale | Standard Deviation 6 |
| Weight Loss and Weight Maintenance | Change in Quality of Life | General Health Quality of Life at Baseline | 47.8 units on a scale | Standard Deviation 7 |
| Weight Loss and Weight Maintenance | Change in Quality of Life | General Health Quality of Life at Study End | 52.0 units on a scale | Standard Deviation 8.6 |
| Control | Change in Quality of Life | General Health Quality of Life at Baseline | 48.0 units on a scale | Standard Deviation 7.8 |
| Control | Change in Quality of Life | General Health Quality of Life at Pre-Surgery | 48.6 units on a scale | Standard Deviation 8.5 |
| Control | Change in Quality of Life | General Health Quality of Life at Study End | 47.7 units on a scale | Standard Deviation 8.9 |
Comparison: Difference between groups from Baseline to Study End.p-value: 0.09Mixed Models Analysis
Comparison: Difference between groups from baseline to pre-surgery.p-value: 0.04Mixed Models Analysis
Secondary
Change in Weight
Body weight will be measured at participant study visits.
Time frame: Change from Baseline to Month 6
Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss and Weight Maintenance | Change in Weight | Baseline body weight (kg) | 106.9 weight in kilograms | Standard Deviation 17.2 |
| Weight Loss and Weight Maintenance | Change in Weight | 1 week prior to surgery body weight (kg) | 101.1 weight in kilograms | Standard Deviation 16.5 |
| Weight Loss and Weight Maintenance | Change in Weight | 6 months after surgery body weight (kg) | 95.8 weight in kilograms | Standard Deviation 17.5 |
| Control | Change in Weight | Baseline body weight (kg) | 101.5 weight in kilograms | Standard Deviation 10.4 |
| Control | Change in Weight | 1 week prior to surgery body weight (kg) | 100.6 weight in kilograms | Standard Deviation 11.1 |
| Control | Change in Weight | 6 months after surgery body weight (kg) | 99.8 weight in kilograms | Standard Deviation 11.1 |
p-value: <0.0001Mixed Models Analysis
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.
Time frame: Change from Baseline to Month 6
Population: Intent to Treat Population (all participants assigned to Weight Loss and Weight Maintenance or Control).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss and Weight Maintenance | 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 |
| Weight Loss and Weight Maintenance | 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 |
| Weight Loss and Weight Maintenance | 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 |
| Control | 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 0.27 |
| Control | Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors | 1 week prior to surgery leptin/adiponectin ratio | 0.29 leptin/adiponectin ratio | Standard Deviation 0.22 |
| Control | Impact of Weight Loss Before and Weight Maintenance After PCa Surgery on Inflammation Factors | 6 months after surgery leptin/adiponectin ratio | 0.25 leptin/adiponectin ratio | Standard Deviation 0.32 |
p-value: 0.0323Mixed Models Analysis