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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Time Up and Go tests (TUG test)
研究概览
简要总结
This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active Therapy
Pulsed electromagnetic fields therapy will be delivered using the BIXEPS system (QuantumTX, Singapore).
干预措施: Pulsed electromagnetic fields Thearpy (Device)
Sham Therapy
Sham thearpy will be delivered using the BIXEPS system (QuantumTX, Singapore).
干预措施: Sham Therapy (Device)
结局指标
主要结局
Time Up and Go tests (TUG test)
时间窗: 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 Up and Go tests (TUG test)
时间窗: Baseline, Week 5, Week 12
Changes in time for Time Up and Go tests (TUG test) at the end of the 12-week treatment
次要结局
- Appendicular skeletal muscle mass(Baseline, Week 5, Week 12)
- Body Mass Index (BMI)(Baseline, Week 5, Week 12)
- Calf circumference(Baseline, Week 5, Week 12)
- Hand grip Strength(Baseline, Week 5, Week 12)
- Five times sit-to-stand tests(Baseline, Week 5, Week 12)
- Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire(Baseline, Week 5, Week 12)
- Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score(Baseline, Week 5, Week 12)
- Concentration of Cytokines and inflammatory markers(Baseline, Week 5, Week 12)
- Quality of life measured by FACT-P Questionnaire(Baseline, Week 5, Week 12)
- Appendicular skeletal muscle mass(Baseline, Week 5, Week 12)
- Hand grip Strength(Baseline, Week 5, Week 12)
- Body Mass Index (BMI)(Baseline, Week 5, Week 12)
- Calf circumference(Baseline, Week 5, Week 12)
- Five times sit-to-stand tests(Baseline, Week 5, Week 12)
- Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score(Baseline, Week 5, Week 12)
- Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire(Baseline, Week 5, Week 12)
- Concentration of Cytokines and inflammatory markers(Baseline, Week 5, Week 12)
- Quality of life measured by FACT-P Questionnaire(Baseline, Week 5, Week 12)
研究者
NG Chi Fai
Professor
Chinese University of Hong Kong