An exploratory study to determine if exercise can impact the gut microbiota composition of men receiving androgen deprivation therapy for prostate cancer.

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Bowel Function; Cancer - Prostate; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618000280202
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-22
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Men with localised or locally advanced prostate cancer, currently receiving androgen deprivation therapy (ADT) will be eligible to enrol into this study. Men must remain on ADT for the duration of their involvement in the study, and receive medical clearance to participate prior to enrolment.

Age-matched, healthy male volunteers, with no previous or current cancer diagnosis, will be eligible to participate in this study, and will be recruited following the attainment of the two prostate cancer cohorts to ensure approximate balance for age. For inclusion, age-matched, healthy male volunteers will need to receive medical confirmation of their previous and current health status, with no evidence of current major musculoskeletal, cardiometabolic or neurological chronic disease or complications.

Exclusion Criteria

Patients with visceral or bone metastases (i.e. advanced, or castrate-resistant prostate cancer); who have previously received chemotherapy; currently receiving radiation therapy; or who are currently on any experimental therapies will be excluded from this study. Further, men with any physical, mental or other contraindications that could interfere with exercise participation will be excluded. Lastly, men who cannot (or have difficulty) understanding English will also be excluded.

Patients will also be excluded if: their treatment is for secondary cancer; medical records mention cognitive or learning problems; they have had any previous gastrointestinal surgery; and/or if they have taken antibiotics, prebiotics, probiotics, nutritional or ergogenic compliments during the 3 months prior to the study.

Age-matched, healthy male volunteers will be excluded if they cannot provide medical confirmation of their previous / current health status; if they have any current major musculoskeletal, cardiometabolic or neurological chronic disease or complications; medical records mention cognitive or learning problems; they have had any previous gastrointestinal surgery; and/or if they have taken antibiotics, prebiotics, probiotics, nutritional or ergogenic compliments during the 3 months prior to the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified