Soccer-Based Lifestyle in Improving Bone and Metabolic Health in Prostate Cancer Survivors

Active:	Yes
Cancer Type:	Prostate Cancer	NCT ID:	NCT04144127
Trial Phases:		Protocol IDs:	RSPH4684-19 (primary) NCI-2019-05183 IRB00110890
Eligibility:	18 - 79 Years, Male	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04144127

Summary

This trial studies how a physically active lifestyle affects bone and metabolic health in prostate cancer survivors. Treatment for prostate cancer often results in side effects including decreased bone mineral density, loss of lean body mass, and increased fat mass. Exercise, especially recreational team sports such as soccer, may counteract these side effects and improve bone health, body composition, and mental and metabolic health in prostate cancer survivors.

Objectives

PRIMARY OBJECTIVES:
I. Conduct a single-arm clinical trial over 3 months, among prostate cancer (PCa) survivors that had at least 6 months of hormone therapy (i.e. androgen deprivation therapy [ADT] with testosterone lowering agents) within the past 10 years. We will evaluate between-group differences over 6-months in:
Ia. Lumbar spine bone mineral density (BMD) at 3-months.
Ib. Impact on additional markers of bone health including total hip BMD and bone turnover markers (osteocalcin [a marker of bone formation]) and C-terminal telopeptide of collagen [CTx] a bone resorption marker), body composition (weight, body mass index [BMI], percent [%] body fat, waist circumference, lean body mass), cardiometabolic markers (resting heart rate and blood pressure), functional markers (aerobic capacity, muscle strength), behavioral factors (diet and physical activity [PA] self-efficacy, dietary intake, smoking and alcohol habits, weekly steps, sedentary and sleep time) and patient-reported quality of life and depression symptoms.
II. To assess implementation feasibility and evaluate overall efficacy to increase engagement and adherence with PA, we will evaluate between-group differences over 3 months in:
IIa. Compliance with recommendations of 150 minutes of moderate-to-vigorous PA/week.
IIb. To assess the recreational soccer (RS) program adherence and tolerance.

OUTLINE:
Patients participate in soccer conditioning drills and other fitness routines twice per week over 60 minutes and meet with a coach after each session to discuss diet and behavior change education over 26 weeks. Patients also wear a fitness tracker to measure steps and activity.

After completion of study, patients are followed up at 6 months.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.