Prince of Wales Hospital
Shatin, Hong Kong
Location status: Recruiting
NCT Number: NCT07057375
This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Shatin, Hong Kong
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline, Week 5, Week 12
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
Changes in appendicular skeletal muscle mass at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Changes in BMI at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Changes in calf circumference at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
Changes in hand grip strength at the end of the 12-week treatment
Time frame: Baseline, Week 5, Week 12
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 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
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
Changes in a panel of cytokines and inflammatory markers at the end of 12 week treatment
Time frame: Baseline, Week 5, Week 12
The higher the score, the better of Quality of life
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
A Prospective Randomized Study to Investigate the Effect of Pulsed Electromagnetic Field Therapy on Muscle Mass and Muscle Strength in Prostate Cancer Patients Treated With Androgen Deprivation Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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