- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06851988
면역 노후화를 개선하여 두부 및 목 암 환자의 재발을 줄일 수 있습니다.
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wan-Chin Kuo
- 전화번호: 3708 03-3196200
- 이메일: troublefup6@cgmh.org.tw
연구 연락처 백업
- 이름: Kuo
연구 장소
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New Taipei City, 대만, 23652
- 모병
- TuCheng Hospital
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연락하다:
- Chia-Hsun Hsieh, PhD
- 전화번호: 0975366137
- 이메일: wisdom5000@cgmh.org.tw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
간섭 없음: Head and Neck patient after CCRT treatment-Experimental group
keep follow the PFS and OS |
|
|
실험적: 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. |
|
간섭 없음: Head and Neck patient after CCRT treatment-Validation group
keep follow the PFS and OS |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
percent of participants with phenoage and age
기간: baseline before CCRT
|
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age. |
baseline before CCRT
|
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percent of participants with phenoage and age
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 의자: Chia-Hsun Hsieh, New Tipei City Tucheng Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .