Energy Balance for Prostate Cancer Survivorship

Prostate Cancer Clinical Trial

Official title:

Energy Balance for Prostate Cancer Survivorship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252484
• Other study ID #: STUDY00001274
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: September 6, 2016
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: University of Kansas Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.

Description:

The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:

1. Diet

2. Physical activity

3. Coaching

4. Diet and exercise monitoring tool

The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 72 Years

Eligibility

Inclusion Criteria:

• Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)

• Body Mass Index (BMI) 25-45 kg/m2

• Have internet access

• Have an iPad/iPhone/iDevice

Exclusion Criteria:

• History of 5 alpha reductase inhibitors prior 3 months

• History of radiation therapy

• Taking active cancer treatment

• Undergoing salvage therapy

• Castration-resistant prostate cancer

• Evidence of metastasis

• Evidence of biochemical recurrence

• High risk medical condition (e.g. gout or kidney disease)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Weight Loss Program
Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.
• Standard of Care
Standard of Care for this patient population.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Jill Hamilton-Reeves, PhD RD LD	University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight during the post-surgical period		Change from Surgery to Week 20	No
Secondary	Changes in body weight during the pre-surgical weight-loss intervention		Change from Baseline to Week 8	No
Secondary	Changes in diet quality during the pre-surgical weight-loss intervention	Changes will be measured by analyzing results from alternative healthy eating index scores.	Change from Baseline to Week 8	No
Secondary	Prostate cancer status	Evidence of recurrence of cancer	Week 20	No
Secondary	Change in cardiovascular biomarkers	Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.	Change from Baseline to Week 20	No