Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy (WARRIOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03261271|
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Prostate Cancer||Behavioral: Weight Loss Program Behavioral: Standardized educational flyer Behavioral: Weight Maintenance Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy|
|Actual Study Start Date :||August 28, 2017|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: 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.
Behavioral: Weight Loss Program
Program involves one-on-one coaching, diet meal plan, and physical activity plan.
Behavioral: Weight Maintenance Program
Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
Active Comparator: Control
Participants will receive a standardized educational flyer about a healthy diet and exercise.
Behavioral: 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 [ Time Frame: Change from Baseline to Month 6 ]Impact will be measured by changes in specific blood immune biomarker biomarkers.
- Impact of weight loss before and weight maintenance after PCa surgery on inflammation factors [ Time Frame: Change from Baseline to Month 6 ]Impact will be measured by changes in specific blood inflammation biomarkers.
- Change in weight [ Time Frame: Change from Baseline to Month 6 ]
- Change in body composition [ Time Frame: Change from Baseline to Prior to Surgery, from 4 to 16 weeks ]Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA).
- Change in Quality of Life [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261271
|Contact: Misty Bechtelemail@example.com|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Jill Hamilton-Reeves, PhD||University of Kansas Medical Center|