This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
110
Pulsed electromagnetic fields (PEMF) is a non-invasive and non-thermal treatment used to stimulate muscle regeneration, resulting in increased muscle mass and strength.
Sham Therapy
Prince of Wales Hospital
Shatin, Hong Kong
RECRUITINGTime Up and Go tests (TUG test)
Changes in time for Time Up and Go tests (TUG test) at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Appendicular skeletal muscle mass
Changes in appendicular skeletal muscle mass at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Body Mass Index (BMI)
Changes in BMI at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Calf circumference
Changes in calf circumference at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Hand grip Strength
Changes in hand grip strength at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Five times sit-to-stand tests
Changes in time for Five times sit-to-stand tests at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire
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
Time frame: Baseline, Week 5, Week 12
Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score
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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
Time frame: Baseline, Week 5, Week 12
Concentration of Cytokines and inflammatory markers
Changes in a panel of cytokines and inflammatory markers at the end of 12 week treatment
Time frame: Baseline, Week 5, Week 12
Quality of life measured by FACT-P Questionnaire
The higher the score, the better of Quality of life
Time frame: Baseline, Week 5, Week 12