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Může vykonávat zlepšení imunosenescence a tím snižovat relaps u pacientů s rakovinou hlavy a krku

21. září 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

290

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Kuo

Studijní místa

      • New Taipei City, Tchaj-wan, 23652
        • Nábor
        • TuCheng Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.

Žádný zásah: Head and Neck patient after CCRT treatment-Experimental group

keep follow the PFS and OS

Experimentální: 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.

Žádný zásah: Head and Neck patient after CCRT treatment-Validation group

keep follow the PFS and OS

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
percent of participants with phenoage and age
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Studijní židle: Chia-Hsun Hsieh, New Tipei City Tucheng Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. května 2023

Primární dokončení (Odhadovaný)

30. října 2026

Dokončení studie (Odhadovaný)

30. října 2026

Termíny zápisu do studia

První předloženo

21. února 2024

První předloženo, které splnilo kritéria kontroly kvality

24. února 2025

První zveřejněno (Aktuální)

28. února 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 202201332B0

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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