Prostate Cancer
Conditions
Keywords
ADT
Brief summary
This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.
Detailed description
This randomised parallel-group study assesses the efficacy, safety and tolerability of Pulsed electromagnetic fields (PEMF) on the muscle mass and strength in PCa patients treated with ADT.Treatment will be delivered using the BIXEPS system (QuantumTX, Singapore). During each treatment, the subject's quadriceps (thigh) region will be put into the machine and treated for 10 minutes for each lower limbs. The whole treatment consists of 1 therapy session per week for 12 weeks. The two lower limbs will be treated alternatively during the treatment. A set of assessments, including body composition assessment, muscle function assessment, questionnaire assessment, and blood and urine for inflammation and cytokines measurement, will be performed at baseline before the start of the first treatment, week 5 and week 12.
Interventions
DEVICEPulsed electromagnetic fields Thearpy
Pulsed electromagnetic fields (PEMF) is a non-invasive and non-thermal treatment used to stimulate muscle regeneration, resulting in increased muscle mass and strength.
DEVICESham Therapy
Sham Therapy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with age greater than or equal to 18 years old. * Histologically documented PCa * No evidence of distant metastasis (M1 disease) * With ADT exposure from six months to three years * Expected to continue for at least six months * At least four weeks after radical prostatectomy or completed radiotherapy
Exclusion criteria
* Patients are still under active treatment, such as radiotherapy * Patients who are unable to walk for 400 m or undertake exercise that will affect the clinical assessment of muscle strength * Patients with amputated lower limbs or other body deformities that will affect the treatment protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Up and Go tests (TUG test) | Baseline, Week 5, Week 12 | Changes in time for Time Up and Go tests (TUG test) at the end of the 12-week treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | Baseline, Week 5, Week 12 | Changes in BMI at the end of the 12-week treatment |
| Calf circumference | Baseline, Week 5, Week 12 | Changes in calf circumference at the end of the 12-week treatment |
| Hand grip Strength | Baseline, Week 5, Week 12 | Changes in hand grip strength at the end of the 12-week treatment |
| Five times sit-to-stand tests | Baseline, Week 5, Week 12 | Changes in time for Five times sit-to-stand tests at the end of the 12-week treatment |
| Appendicular skeletal muscle mass | Baseline, Week 5, Week 12 | Changes in appendicular skeletal muscle mass at the end of the 12-week treatment |
| Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score | Baseline, Week 5, Week 12 | Changes in SARC-F scores at the end of the 12-week treatment. The score equal to or greater than 4 is predictive of sarcopenia |
| Concentration of Cytokines and inflammatory markers | Baseline, Week 5, Week 12 | Changes in a panel of cytokines and inflammatory markers at the end of 12 week treatment |
| Quality of life measured by FACT-P Questionnaire | Baseline, Week 5, Week 12 | The higher the score, the better of Quality of life |
| Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire | Baseline, Week 5, Week 12 | Quality of life measured by ED-5Q-5L questionnaire, which include the the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS range from 0 to 100).the higher the score the better in quality of life |
Countries
Hong Kong
Contacts
Primary ContactChi Fai NG, MD
Outcome results
None listed