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Trial record 47 of 1543 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT02969577
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Exercise Program Behavioral: Diet and Nutrition Coaching Other: Usual Care with Attention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Staying Strong & Healthy Intervention (SS&H)
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.
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.

Behavioral: 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.

Active Comparator: Usual Care with Attention (UCA)
Participants will receive the usual care they would normally receive if not taking part in this study.
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.




Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: Change from Baseline to Month 6 ]

Secondary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: Change from Baseline to Month 3 ]
  2. Change in Body Mass Index (BMI) [ Time Frame: Change from Baseline to Month 12 ]
  3. Change in Lipid Profile [ Time Frame: Change from Baseline to Month 3 ]
  4. Change in Lipid Profile [ Time Frame: Change from Baseline to Month 6 ]
  5. Change in Lipid Profile [ Time Frame: Change from Baseline to Month 12 ]
  6. Change in Waist/Hip Circumference [ Time Frame: Change from Baseline to Month 3 ]
  7. Change in Waist/Hip Circumference [ Time Frame: Change from Baseline to Month 6 ]
  8. Change in Waist/Hip Circumference [ Time Frame: Change from Baseline to Month 12 ]
  9. Change in Glucose [ Time Frame: Change from Baseline to Month 3 ]
  10. Change in Glucose [ Time Frame: Change from Baseline to Month 6 ]
  11. Change in Glucose [ Time Frame: Change from Baseline to Month 12 ]
  12. Change in Health Related Quality [ Time Frame: Change from Baseline to Month 3 ]
    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.

  13. Change in Health Related Quality [ Time Frame: Change from Baseline to Month 6 ]
    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.

  14. Change in Health Related Quality [ Time Frame: Change from Baseline to Month 12 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969577


Contacts
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Contact: Alana Enslein, MS 913-588-2468 aenslein@kumc.edu

Locations
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United States, California
University of California, Los Angeles Completed
Los Angeles, California, United States, 90095
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Sally Maliski, PhD, RN, FAAN University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02969577     History of Changes
Other Study ID Numbers: STUDY00004205
R01NR014518 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Androgen deprivation therapy
ADT
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs