- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06851988
Může vykonávat zlepšení imunosenescence a tím snižovat relaps u pacientů s rakovinou hlavy a krku
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
Postavení
Intervence / Léčba
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
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Wan-Chin Kuo
- Telefonní číslo: 3708 03-3196200
- E-mail: troublefup6@cgmh.org.tw
Studijní záloha kontaktů
- Jméno: Kuo
Studijní místa
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-
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New Taipei City, Tchaj-wan, 23652
- Nábor
- TuCheng Hospital
-
Kontakt:
- Chia-Hsun Hsieh, PhD
- Telefonní číslo: 0975366137
- E-mail: wisdom5000@cgmh.org.tw
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age ≥20
- Pathology:Squamous cell carcinoma
- Need CCRT treatment
- ECOG PS<2
- Agree with blood drawing, excise training, questionnaire
Exclusion Criteria:
- ECOG PS≥2
- Unable to tolerate basic exercise, or CCRT treatment
- Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable
- Any medical condition that unsuitable for exercise
- Disagree to trial procedures: exercise, blood draws, questionnaire
Studijní plán
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
Sponzor
Vyšetřovatelé
- Studijní židle: Chia-Hsun Hsieh, New Tipei City Tucheng Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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