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

NCT ID: NCT07057375

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active Therapy

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

Group Type ACTIVE_COMPARATOR

Pulsed electromagnetic fields Thearpy

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Sham Therapy

Intervention Type DEVICE

Sham Therapy

Interventions

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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.

Intervention Type DEVICE

Sham Therapy

Sham Therapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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NG Chi Fai

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi Fai NG, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Chi Fai NG, MD

Role: CONTACT

3505 2625

Facility Contacts

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Chi Fai NG, MD

Role: primary

3505 2625

References

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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.

Reference Type BACKGROUND
PMID: 22649143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12072048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27716195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23234628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16189261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12679426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17146309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8445433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19910811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25999704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9426724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25877953 (View on PubMed)

Other Identifiers

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CRE-2024.600-T

Identifier Type: -

Identifier Source: org_study_id

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