Impact of resistance training on androgen deprivation-induced adverse effects on protein metabolism, body composition and muscle function in prostate cancer patients

Not Applicable

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12616001311448
• Lead Sponsor: Blacktown Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1.ECOG less than or equal to 1; histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only (less than or equal to 5 sites of bone metastases only);
2.Plan to receive at least 12 months continuous androgen deprivation therapy by a GnRH agonist;
3.Normal insulin sensitivity, assessed by co-investigators;
4.Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study;

Exclusion Criteria

1.Any acute condition or exacerbation of chronic conditions that in the investigators opinion would interfere with the trial visit schedule and procedures.
2.Concurrent chemotherapy or anti-androgen therapy;
3.Previous androgen deprivation therapy within last 12 months;
4.Hypothalamic or pituitary disorders, cancer other than prostate cancer, diabetes mellitus and chronic renal or hepatic illnesses;
5.Any medications known to interfere with the endocrine system (apart from ADT);
6.People in existing dependent or unequal relationships with any member of the research team;
7.People who may be involved in illegal activity;
8.People highly dependent on medical care;
9.Patients who had received an investigational new drug within the last 6 month;
10.Patients with a cognitive impairment, an intellectual disability or a mental condition which interfere with the patient's ability to understand the requirements of the study;
11.Inability to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite protein and urea turnover assessed by using stable isotopes, measured by GCMS.[6 weeks post commencement of intervention];Muscle mass assessed by DXA [12 months post commencement of intervention];Muscle function, assessed by cycle ergometer and dynamometer[12 months post commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity, assessed by oral glucose tolerance test[6 weeks, 6 months and 12 months post commencement of intervention];Bone turnover by serum assay[6 months and 12 months post commencement of intervention];Composite energy expenditure and substrate oxidation, assessed by indirect calorimeter[6 weeks, 6 months and 12 months post commencement of intervention]