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Supervised exercises for reducing the side effects of prostate cancer treatment

Optimising adherence with a customised flexible multimodal exercise regimen in prostate cancer patients on radiation and androgen deprivation therapy - HERACLES

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064573
Enrollment
175
Registered
2024-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: A semi-supervised flexible multimodal exercise regimen: The patients randomised to the study arm will meet with the physiotherapy team for advice regarding the exercise regimen to be fo

Sponsors

Tata Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Changes in the Quality of Life as measured by FACIT-FTimepoint: At 24 weeks and at 36 weeks after the start of ADT

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactMoses Arunsingh

Tata Medical Center, Kolkata

moses.arunsingh@tmckolkata.com03366057000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026