Supervised exercises for reducing the side effects of prostate cancer treatment
Phase 3
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2024/03/064573
- Lead Sponsor
- Tata Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Confirmed prostatic carcinoma
2. Will undergo radiation therapy - radical radiation therapy or prostate-directed radiation therapy
3. Is on androgen deprivation therapy with either medical or surgical methods and is planned to be on this for a minimum duration of 6 months
4. ECOG Performance status 0-1
5. Signed study-specific consent form
6. Patient willing and reliable for follow-up
Exclusion Criteria
Patients should have none of the following
1. ECOG Performance status 2 or more
2. Limitation in mobility and/or comorbidities that will prevent them from complying to exercise requirements
3. Unable to follow up or poor logistic or social support
4. Deemed to be at high risk of harm due to the presence of lytic bone metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the Quality of Life as measured by FACIT-FTimepoint: At 24 weeks and at 36 weeks after the start of ADT
- Secondary Outcome Measures
Name Time Method Adherence to the prescribed exercise protocol measured at 24 weeks and at 36 weeks after the start of ADTTimepoint: At 24 weeks and at 36 weeks after the start of ADT;Body Composition of the patientsTimepoint: At 24 weeks and at 36 weeks after the start of ADT;Changes in the Quality of Life as measured by FACT-G and EORTC - PR25Timepoint: At 24 weeks and at 36 weeks after the start of ADT;Functional performance of the patientsTimepoint: At 24 weeks and at 36 weeks after the start of ADT