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Może ćwiczyć poprawę immunosenescencji, a tym samym zmniejszyć nawrót u pacjentów z rakiem głowy i szyi

21 września 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

290

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

  • Nazwa: Kuo

Lokalizacje studiów

      • New Taipei City, Tajwan, 23652
        • Rekrutacyjny
        • TuCheng Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Brak interwencji: Head and Neck patient after CCRT treatment-Experimental group

keep follow the PFS and OS

Eksperymentalny: 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.

Brak interwencji: Head and Neck patient after CCRT treatment-Validation group

keep follow the PFS and OS

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
percent of participants with phenoage and age
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Krzesło do nauki: Chia-Hsun Hsieh, New Tipei City Tucheng Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

3 maja 2023

Zakończenie podstawowe (Szacowany)

30 października 2026

Ukończenie studiów (Szacowany)

30 października 2026

Daty rejestracji na studia

Pierwszy przesłany

21 lutego 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 lutego 2025

Pierwszy wysłany (Rzeczywisty)

28 lutego 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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