Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

University of Kansas

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Exercise Program; Other: Usual Care with Attention; Behavioral: Diet and Nutrition Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02969577

R01NR014518 (U.S. NIH Grant/Contract)

STUDY00004205

Details and patient eligibility

About

The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

Full description

Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).

Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:

1. Staying Strong & Healthy Intervention + Usual Care
2. Usual Care

All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong & Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.

Enrollment: 38 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with prostate cancer
• Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
• Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
• Able to speak and read in English or Spanish
• Reachable consistently by telephone
• Able to travel to KUMC

Exclusion criteria

• Not diagnosed with prostate cancer
• Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
• Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
• Not able to speak and read in English or Spanish
• Not reachable consistently by telephone
• Not able to travel to the study site for data collection

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Staying Strong & Healthy Intervention (SS&H)

Experimental group

Description:

Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.

Treatment:

Other: Usual Care with Attention

Behavioral: Diet and Nutrition Coaching

Behavioral: Exercise Program

Usual Care with Attention (UCA)

Active Comparator group

Description:

Participants will receive the usual care they would normally receive if not taking part in this study.

Treatment:

Other: Usual Care with Attention