Clinical trial NCT02969577: Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
Official title: Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Androgen deprivation therapy
ADT
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-11-21
Enrollment: 38
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in LDL
timeFrame: Change from Baseline to Month 12
Secondary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Change from Baseline to Month 6
measure: Change in Body Mass Index (BMI)
timeFrame: Change from Baseline to Month 12
measure: Change in Lipid Profile
timeFrame: Change from Baseline to Month 6
measure: Change in Lipid Profile
timeFrame: Change from Baseline to Month 12
measure: Change in Waist/Hip Circumference
timeFrame: Change from Baseline to Month 6
measure: Change in Waist/Hip Circumference
timeFrame: Change from Baseline to Month 12
measure: Change in Glucose
timeFrame: Change from Baseline to Month 6
measure: Change in Glucose
timeFrame: Change from Baseline to Month 12
measure: Change in Health Related Quality
timeFrame: Change from Baseline to Month 6
measure: Change in Health Related Quality
timeFrame: Change from Baseline to Month 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Sally Maliski, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References: