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NCT Number: NCT07057375

The Effect of Pulsed Electromagnetic Field Therapy on Muscle Mass and Muscle Strength in Prostate Cancer Patients Treated With Androgen Deprivation Therapy

This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Location status: Recruiting

Location contact

Chi Fai NG, MD

CONTACT

[email protected]

3505 2625

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed electromagnetic fields Thearpy

Device

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

Device

Sham Therapy

Primary outcomes

  1. Time Up and Go tests (TUG test)

    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

Secondary outcomes

  1. Appendicular skeletal muscle mass

    Time frame: Baseline, Week 5, Week 12

    Changes in appendicular skeletal muscle mass at the end of the 12-week treatment

  2. Body Mass Index (BMI)

    Time frame: Baseline, Week 5, Week 12

    Changes in BMI at the end of the 12-week treatment

  3. Calf circumference

    Time frame: Baseline, Week 5, Week 12

    Changes in calf circumference at the end of the 12-week treatment

  4. Hand grip Strength

    Time frame: Baseline, Week 5, Week 12

    Changes in hand grip strength at the end of the 12-week treatment

  5. Five times sit-to-stand tests

    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

  6. Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire

    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

  7. Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score

    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

  8. Concentration of Cytokines and inflammatory markers

    Time frame: Baseline, Week 5, Week 12

    Changes in a panel of cytokines and inflammatory markers at the end of 12 week treatment

  9. Quality of life measured by FACT-P Questionnaire

    Time frame: Baseline, Week 5, Week 12

    The higher the score, the better of Quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Fai NG, MD

CONTACT

[email protected]

3505 2625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

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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