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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
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity Prostate Cancer Behavioral: Weight Loss Program Behavioral: Standardized educational flyer Behavioral: Weight Maintenance Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in weight [ Time Frame: Change from Baseline to Month 6 ]
  3. 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).

  4. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

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


Contacts
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Contact: Misty Bechtel 913-945-5037 mbechtel2@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
American Cancer Society, Inc.
Investigators
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Principal Investigator: Jill Hamilton-Reeves, PhD University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03261271    
Other Study ID Numbers: STUDY00141060
RSG-17-050-01-NEC ( Other Grant/Funding Number: American Cancer Society )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases