Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Può esercitare un'immunosenescence migliorata e quindi ridurre la ricaduta nei malati di carcinoma della testa e del collo

21 settembre 2026 aggiornato da: Jason Chia-Hsun Hsieh, Chang Gung Memorial Hospital

Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will encourage and promise and add further support to the concept that exercise prescription is worth implementation as part of care for the patients with head and neck cancer.

Panoramica dello studio

Descrizione dettagliata

Cancer patients have theoretically returned to a disease-free state after receiving curative anticancer therapy, but even after receiving adjuvant concurrent chemoradiotherapy, it does not ideally prevent all cancer recurrences. For that, several guidelines recommend that cancer survivors participate in regular exercise. Exercise has been thought to be associated with improved outcomes and mortality in healthy individuals as well as in certain cancer populations. However, while the most robust evidence has been demonstrated in patients with prostate, breast and colorectal cancers, the effectiveness of exercise interventions in Head and Neck cancer survivors remains inadequately understood.

Aging of the immune system (so-called immunosenescence) has long been known to increase the risk of infection, cancer, chronic inflammatory diseases and age-related multi-morbidity in humans. In the literature, patients with oral cavity cancer are also believed to have the phenomenon of immune aging (immunosenescence). One of the mechanisms that maintain cellular homeostasis and prevent immunosenescence-related damage is autophagy, a cell-survival mechanism, and it has been proposed as one of the most powerful antiaging therapies. Regular exercise can reestablish autophagy, probably through AMP-activated protein kinase activation, and help in reducing the age-related senescence diseases. At present, many research teams in cancer centers are trying to design large-scale prospective trials to answer whether the intervention of exercise can avoid cancer occurrence, health promotion in survivors, and prevention of recurrence.

This project focuses on the integration of the basic and clinical research. The multidisciplinary research team consists of members from the Department of Hematology and Oncology and Department of Rehabilitation of the New Taipei City Tucheng Hospital and Linkou Chang Gung Memorial Hospital. The main purpose of this three-year project is to investigate whether high-intensity interval training (HIIT) along with resistance exercise intervention, which could reduce the recurrence rate by ameliorating immunosenescence on patients with head and neck cancer. The main tasks order by year of this project are as the following: (1) investigating the differences of immunosenescence indicators in blood with before and after conducting eight weeks of HIIT along with resistance exercise training for patients with head and neck cancer (1st year plan); (2) recruiting new subjects, gathering the physical activity at home and the cancer recurrence rate for first-year subjects, investigating the differences of immunosenescence indicators and immune indicators in the peripheral blood, and examining the clinical effectiveness of exercise training (2nd year plan); (3) Tracking the clinical data and research materials for subjects recruited during the first and second years (3rd year plan). Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will provide promising evidence and add further support to the concept that exercise prescription is worth implementation as part of care for the patients with head and neck cancer.

Tipo di studio

Interventistico

Iscrizione (Stimato)

290

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Kuo

Luoghi di studio

      • New Taipei City, Taiwan, 23652
        • Reclutamento
        • TuCheng Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Age ≥20
  2. Pathology:Squamous cell carcinoma
  3. Need CCRT treatment
  4. ECOG PS<2
  5. Agree with blood drawing, excise training, questionnaire

Exclusion Criteria:

  1. ECOG PS≥2
  2. Unable to tolerate basic exercise, or CCRT treatment
  3. Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable
  4. Any medical condition that unsuitable for exercise
  5. Disagree to trial procedures: exercise, blood draws, questionnaire

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Head and Neck patient after CCRT treatment with HIIT training-Experimental group

After CCRT treatment 4-5 week arrange HIIT training for patient. Two to three times a week ,total 24-36 times.

keep follow the PFS and OS

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times. And record of physical activities at home. According to the record set goal to acheive.

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times.

Nessun intervento: Head and Neck patient after CCRT treatment-Experimental group

keep follow the PFS and OS

Sperimentale: Head and Neck patient after CCRT treatment with HIIT training-Validation group

After CCRT treatment 4-5 week arrange HIIT training for patient. Two to three times a week ,total 24-36 times.

keep follow the PFS and OS

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times. And record of physical activities at home. According to the record set goal to acheive.

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times.

Nessun intervento: Head and Neck patient after CCRT treatment-Validation group

keep follow the PFS and OS

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
percent of participants with phenoage and age
Lasso di tempo: baseline before CCRT

To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.

baseline before CCRT
percent of participants with phenoage and age
Lasso di tempo: 1 months after the completion of CCRT

To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.

1 months after the completion of CCRT
percent of participants with phenoage and age
Lasso di tempo: 6 months after the completion of CCRT

To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.

6 months after the completion of CCRT
percent of participants with phenoage and age
Lasso di tempo: 9 months after the completion of CCRT

To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.

9 months after the completion of CCRT
Peak VO2 (ml/min/kg) of participants
Lasso di tempo: baseline before CCRT

To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training

baseline before CCRT
Peak VO2 (ml/min/kg) of participants
Lasso di tempo: 1 months after the completion of CCRT

To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training.The higher scores mean a better outcome.

1 months after the completion of CCRT
Peak VO2 (ml/min/kg) of participants
Lasso di tempo: 6 months after the completion of CCRT

To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training.The higher scores mean a better outcome.

6 months after the completion of CCRT
Peak VO2 (ml/min/kg) of participants
Lasso di tempo: 9 months after the completion of CCRT

To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training. The higher scores mean a better outcome.

9 months after the completion of CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Lasso di tempo: baseline before CCRT

To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.

baseline before CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Lasso di tempo: 1 month after the completion of CCRT

To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.

1 month after the completion of CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Lasso di tempo: 6 month after the completion of CCRT

To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.

6 month after the completion of CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Lasso di tempo: 9 month after the completion of CCRT

To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.

9 month after the completion of CCRT

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Chia-Hsun Hsieh, New Tipei City Tucheng Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 maggio 2023

Completamento primario (Stimato)

30 ottobre 2026

Completamento dello studio (Stimato)

30 ottobre 2026

Date di iscrizione allo studio

Primo inviato

21 febbraio 2024

Primo inviato che soddisfa i criteri di controllo qualità

24 febbraio 2025

Primo Inserito (Effettivo)

28 febbraio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 202201332B0

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi