Energy Balance for Prostate Cancer Survivorship

Jill Hamilton-Reeves, PhD RD LD

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Weight Loss Program; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02252484

STUDY00001274

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 50 to 72 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Weight loss intervention Group

Experimental group

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.

Treatment:

Other: Weight Loss Program

Comparison Group

Active Comparator group

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.

Treatment:

Other: Standard of Care