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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969577
• Other study ID #: STUDY00004205
• Secondary ID: R01NR014518
• Status: Completed
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Exercise Program
Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.
• Diet and Nutrition Coaching
Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.

Other:
• Usual Care with Attention
Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL		Change from Baseline to Month 12
Secondary	Change in Body Mass Index (BMI)		Change from Baseline to Month 6
Secondary	Change in Body Mass Index (BMI)		Change from Baseline to Month 12
Secondary	Change in Lipid Profile		Change from Baseline to Month 6
Secondary	Change in Lipid Profile		Change from Baseline to Month 12
Secondary	Change in Waist/Hip Circumference		Change from Baseline to Month 6
Secondary	Change in Waist/Hip Circumference		Change from Baseline to Month 12
Secondary	Change in Glucose		Change from Baseline to Month 6
Secondary	Change in Glucose		Change from Baseline to Month 12
Secondary	Change in Health Related Quality	Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.	Change from Baseline to Month 6
Secondary	Change in Health Related Quality	Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.	Change from Baseline to Month 12