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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Sham Therapy; Device: Pulsed electromagnetic fields Thearpy

Study type: Interventional

Funder types: Other

Identifiers

NCT07057375

CRE-2024.600-T

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

110 participants in 2 patient groups

Active Therapy

Active Comparator group

Description:

Pulsed electromagnetic fields therapy will be delivered using the BIXEPS system (QuantumTX, Singapore).

Treatment:

Device: Pulsed electromagnetic fields Thearpy

Sham Therapy

Sham Comparator group

Description:

Sham thearpy will be delivered using the BIXEPS system (QuantumTX, Singapore).

Treatment:

Device: Sham Therapy