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Energy Balance for Prostate Cancer Survivorship

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Weight Loss Program

Standard of Care

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer, prostatectomy, weight loss, prevent weight gain

Eligibility Criteria

50 Years - 72 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight loss intervention Group

Comparison Group

Arm Description

Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.

All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.

Outcomes

Primary Outcome Measures

Change in body weight during the post-surgical period

Secondary Outcome Measures

Changes in body weight during the pre-surgical weight-loss intervention

Changes in diet quality during the pre-surgical weight-loss intervention

Changes will be measured by analyzing results from alternative healthy eating index scores.

Prostate cancer status

Evidence of recurrence of cancer

Change in cardiovascular biomarkers

Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.

Full Information

NCT ID

NCT02252484

First Posted

September 18, 2014

Last Updated

September 6, 2016

Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02252484

Brief Title

Energy Balance for Prostate Cancer Survivorship

Official Title

Energy Balance for Prostate Cancer Survivorship

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

University of Kansas Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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: Diet Physical activity Coaching 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, prostatectomy, weight loss, prevent weight gain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight loss intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Comparison Group

Arm Type

Active Comparator

Arm Description

All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.

Intervention Type

Other

Intervention Name(s)

Weight Loss Program

Intervention Description

Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Standard of Care for this patient population.

Primary Outcome Measure Information:

Title

Change in body weight during the post-surgical period

Time Frame

Change from Surgery to Week 20

Secondary Outcome Measure Information:

Title

Changes in body weight during the pre-surgical weight-loss intervention

Time Frame

Change from Baseline to Week 8

Title

Changes in diet quality during the pre-surgical weight-loss intervention

Description

Changes will be measured by analyzing results from alternative healthy eating index scores.

Time Frame

Change from Baseline to Week 8

Title

Prostate cancer status

Description

Evidence of recurrence of cancer

Time Frame

Week 20

Title

Change in cardiovascular biomarkers

Description

Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.

Time Frame

Change from Baseline to Week 20

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jill Hamilton-Reeves, PhD, RD, LD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33295204

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.

Results Reference

derived

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Energy Balance for Prostate Cancer Survivorship

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