- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06851988
Kan udøve forbedring af immunosenescens og derved reducere tilbagefald hos patienter med hoved og hals kræft
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Wan-Chin Kuo
- Telefonnummer: 3708 03-3196200
- E-mail: troublefup6@cgmh.org.tw
Undersøgelse Kontakt Backup
- Navn: Kuo
Studiesteder
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New Taipei City, Taiwan, 23652
- Rekruttering
- TuCheng Hospital
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Kontakt:
- Chia-Hsun Hsieh, PhD
- Telefonnummer: 0975366137
- E-mail: wisdom5000@cgmh.org.tw
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Ingen indgriben: Head and Neck patient after CCRT treatment-Experimental group
keep follow the PFS and OS |
|
|
Eksperimentel: 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. |
|
Ingen indgriben: Head and Neck patient after CCRT treatment-Validation group
keep follow the PFS and OS |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
percent of participants with phenoage and age
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Chia-Hsun Hsieh, New Tipei City Tucheng Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202201332B0
Plan for individuelle deltagerdata (IPD)
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