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Lo studio clinico NCT07057375 per CANCRO ALLA PROSTATA è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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The Effect of Pulsed Electromagnetic Field Therapy on Muscle Mass and Muscle Strength in Prostate Cancer Patients Treated With Androgen Deprivation Therapy 110

In arruolamento
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La sperimentazione clinica NCT07057375 è uno studio interventistico per CANCRO ALLA PROSTATA, attualmente in arruolamento. Avviato il 1 giugno 2025, prevede di arruolare 110 partecipanti. Sotto la guida di l'Università cinese di Hong Kong, dovrebbe concludersi entro il 31 marzo 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 9 luglio 2025.
Sommario breve
This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.
Descrizione dettagliata
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 trea...Mostra di più
Titolo ufficiale

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

Patologie
CANCRO ALLA PROSTATA
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • CRE-2024.600-T
Numero NCT
NCT07057375
Data di inizio (effettiva)
2025-06-01
Ultimo aggiornamento pubblicato
2025-07-09
Data di completamento (stimata)
2027-03-31
Arruolamento (previsto)
110
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
ADT
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivoActive Therapy
Pulsed electromagnetic fields therapy will be delivered using the BIXEPS system (QuantumTX, Singapore).
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.
Comparatore simulatoSham Therapy
Sham thearpy will be delivered using the BIXEPS system (QuantumTX, Singapore).
Terapia Simulata
Sham Therapy
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
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
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Maschio
  • 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

  • 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
Chinese University of Hong Kong logoUniversità cinese di Hong Kong474 studi clinici attivi da esplorare
Parte responsabile dello studio
NG Chi Fai, Investigatore principale, Professor, Chinese University of Hong Kong
Contatti principali dello studio
Contatto: Chi Fai NG, MD, 3505 2625, [email protected]
1 Centri dello studio in 1 paesi
Prince of Wales Hospital, Shatin, Hong Kong
Chi Fai NG, MD, Contatto, 3505 2625, [email protected]
In arruolamento