Clinical trial NCT02252484: Energy Balance for Prostate Cancer Survivorship
Official title: Energy Balance for Prostate Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
prostatectomy
weight loss
prevent weight gain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
First posted: 2014-09-30
Enrollment: 20
Sex: MALE
Minimum age (years): 50
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in body weight during the post-surgical period
timeFrame: Change from Surgery to Week 20
Secondary outcomes:
measure: Changes in body weight during the pre-surgical weight-loss intervention
timeFrame: Change from Baseline to Week 8
measure: Changes in diet quality during the pre-surgical weight-loss intervention
timeFrame: Change from Baseline to Week 8
measure: Prostate cancer status
timeFrame: Week 20
measure: Change in cardiovascular biomarkers
timeFrame: Change from Baseline to Week 20
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill Hamilton-Reeves, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamilton-Reeves JM, Johnson CN, Hand LK, Bechtel MD, Robertson HL, Michel C, Metcalf M, Chalise P, Mahan NJ, Mirza M, Lee EK, Sullivan DK, Klemp JR, Befort CA, Parker WP, Gibbs HD, Demark-Wahnefried W, Thrasher JB. Feasibility of a Weight Management Program Tailored for Overweight Men with Localized Prostate Cancer - A Pilot Study. Nutr Cancer. 2021;73(11-12):2671-2686. doi: 10.1080/01635581.2020.1856890. Epub 2020 Dec 9.