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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Therapy | Active Comparator | Pulsed electromagnetic fields therapy will be delivered using the BIXEPS system (QuantumTX, Singapore). |
|
| Sham Therapy | Sham Comparator | Sham thearpy will be delivered using the BIXEPS system (QuantumTX, Singapore). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time 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 | Baseline, Week 5, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Appendicular skeletal muscle mass | Changes in appendicular skeletal muscle mass at the end of the 12-week treatment | Baseline, Week 5, Week 12 |
| Body Mass Index (BMI) | Changes in BMI at the end of the 12-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi Fai NG, MD | Contact | 3505 2625 | ngcf@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Chi Fai NG, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Shatin | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22649143 | Background | Smith MR, Saad F, Egerdie B, Sieber PR, Tammela TL, Ke C, Leder BZ, Goessl C. Sarcopenia during androgen-deprivation therapy for prostate cancer. J Clin Oncol. 2012 Sep 10;30(26):3271-6. doi: 10.1200/JCO.2011.38.8850. Epub 2012 May 29. | |
| 12072048 | Background | Basaria S, Lieb J 2nd, Tang AM, DeWeese T, Carducci M, Eisenberger M, Dobs AS. Long-term effects of androgen deprivation therapy in prostate cancer patients. Clin Endocrinol (Oxf). 2002 Jun;56(6):779-86. doi: 10.1046/j.1365-2265.2002.01551.x. |
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| Sham Therapy | Device | Sham Therapy |
|
| Baseline, Week 5, Week 12 |
| Calf circumference | Changes in calf circumference at the end of the 12-week treatment | Baseline, Week 5, Week 12 |
| Hand grip Strength | Changes in hand grip strength at the end of the 12-week treatment | 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 | 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 | Baseline, Week 5, Week 12 |
| Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score | 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 | 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 | Baseline, Week 5, Week 12 |
| Quality of life measured by FACT-P Questionnaire | The higher the score, the better of Quality of life | Baseline, Week 5, Week 12 |
| 27716195 | Background | Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4. |
| 23234628 | Background | Saylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol. 2013 Jan;189(1 Suppl):S34-42; discussion S43-4. doi: 10.1016/j.juro.2012.11.017. |
| 16189261 | Background | Greenspan SL, Coates P, Sereika SM, Nelson JB, Trump DL, Resnick NM. Bone loss after initiation of androgen deprivation therapy in patients with prostate cancer. J Clin Endocrinol Metab. 2005 Dec;90(12):6410-7. doi: 10.1210/jc.2005-0183. Epub 2005 Sep 27. |
| 12679426 | Background | Storer TW, Magliano L, Woodhouse L, Lee ML, Dzekov C, Dzekov J, Casaburi R, Bhasin S. Testosterone dose-dependently increases maximal voluntary strength and leg power, but does not affect fatigability or specific tension. J Clin Endocrinol Metab. 2003 Apr;88(4):1478-85. doi: 10.1210/jc.2002-021231. |
| 17146309 | Background | Galvao DA, Nosaka K, Taaffe DR, Spry N, Kristjanson LJ, McGuigan MR, Suzuki K, Yamaya K, Newton RU. Resistance training and reduction of treatment side effects in prostate cancer patients. Med Sci Sports Exerc. 2006 Dec;38(12):2045-52. doi: 10.1249/01.mss.0000233803.48691.8b. |
| 8445433 | Background | Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570. |
| 19910811 | Background | Hanson ED, Srivatsan SR, Agrawal S, Menon KS, Delmonico MJ, Wang MQ, Hurley BF. Effects of strength training on physical function: influence of power, strength, and body composition. J Strength Cond Res. 2009 Dec;23(9):2627-37. doi: 10.1519/JSC.0b013e3181b2297b. |
| 25999704 | Background | Denison HJ, Cooper C, Sayer AA, Robinson SM. Prevention and optimal management of sarcopenia: a review of combined exercise and nutrition interventions to improve muscle outcomes in older people. Clin Interv Aging. 2015 May 11;10:859-69. doi: 10.2147/CIA.S55842. eCollection 2015. |
| 9426724 | Background | Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997 Dec;50(6):920-8. doi: 10.1016/S0090-4295(97)00459-7. |
| 25877953 | Background | Wong CK, Choi EP, Tsu JH, Ho BS, Ng AT, Chin WY, Yiu MK. Psychometric properties of Functional Assessment of Cancer Therapy-Prostate (FACT-P) in Chinese patients with prostate cancer. Qual Life Res. 2015 Oct;24(10):2397-402. doi: 10.1007/s11136-015-0993-8. Epub 2015 Apr 16. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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