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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Pulsed electromagnetic fields Thearpy
  Pulsed electromagnetic fields (PEMF) is a non-invasive and non-thermal treatment used to stimulate muscle regeneration, resulting in increased muscle mass and strength.
• Устройство Sham Therapy
  Sham Therapy

Первичные конечные точки

• Time Up and Go tests (TUG test) [Срок оценки: Baseline, Week 5, Week 12]

Вторичные конечные точки (9)

• Appendicular skeletal muscle mass [Срок оценки: Baseline, Week 5, Week 12]
• Body Mass Index (BMI) [Срок оценки: Baseline, Week 5, Week 12]
• Calf circumference [Срок оценки: Baseline, Week 5, Week 12]
• Hand grip Strength [Срок оценки: Baseline, Week 5, Week 12]
• Five times sit-to-stand tests [Срок оценки: Baseline, Week 5, Week 12]
• Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire [Срок оценки: Baseline, Week 5, Week 12]
• Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score [Срок оценки: Baseline, Week 5, Week 12]
• Concentration of Cytokines and inflammatory markers [Срок оценки: Baseline, Week 5, Week 12]
• Quality of life measured by FACT-P Questionnaire [Срок оценки: Baseline, Week 5, Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Shatin

Публикации

• 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. PMID 22649143
• 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. PMID 12072048
• 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 PMID 27716195
• 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. PMID 23234628
• 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. PMID 16189261
• 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. PMID 12679426
• 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. PMID 17146309
• 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. PMID 8445433

Идентификаторы

NCT: NCT07057375 · CRE-2024.600-T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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