- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05094310
Genetic Predictors of Response to Acupuncture for Cancer-related Fatigue Among Breast Cancer Patients After Chemotherapy
연구 개요
상세 설명
Cancer related fatigue(CRF) in patients with breast cancer has a great impact on their quality of life and treatment compliance. Many studies suggest that acupuncture has certain therapeutic effects on fatigue. In this clinical trial, we treated patients with acupuncture to alleviate their fatigue symptoms. Currently, studies have shown that cancer related fatigue in breast cancer patients is related to some biological factors. While acupuncture is used to treat fatigue, we will collect blood samples from patients for fatigue related single nucleotide polymorphisms(SNP).
Based on CRF related biological factors, our study aims to screen SNPs that related to CRF related biological factors to guide electroacupuncture in the treatment of cancer-related fatigue and establish a prognostic model.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Qinghai
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Xining, Qinghai, 중국, 810000
- 모병
- Qinghai University Affiliated Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The patient was diagnosed with breast cancer.;
- Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study;
- Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
- Patients with previous local recurrence were eligible, but not patients with distant metastasis;
- The basic indexes were consistent, and the blood routine and ECG were normal.
Exclusion Criteria:
- The exclusion criteria were patients with needle phobia;
- Low platelet count (<50 000); co-morbidity with a bleeding disorder; co-morbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids;
- Life expectancy <6 months;
- lymphoedematous limbs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Acupuncture group
Patients with breast cancer who experienced fatigue were measured by the Brief Fatigue Inventory(BFI) scale and other Fatigue related questionnaire.
Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study,and those patients will receive acupuncture treatment.
The position of acupuncture refers to the principle of acupuncture treatment of traditional Chinese medicine.
According to ICD-10-CD code R53.0, the diagnosis of CRF is determined by the experience of diminished energy or other physical and psychological symptoms every day or almost every day for two consecutive weeks in the past month.
We collected patients' blood to detect fatigue related SNP.
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Patients with breast cancer who experienced fatigue were measured by the Brief Fatigue Inventory(BFI) scale and other Fatigue related questionnaire.
Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study,and those patients will receive acupuncture treatment.
The position of acupuncture refers to the principle of acupuncture treatment of traditional Chinese medicine.
According to ICD-10-CD code R53.0, the diagnosis of CRF is determined by the experience of diminished energy or other physical and psychological symptoms every day or almost every day for two consecutive weeks in the past month.
We collected patients' blood to detect fatigue related SNP.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference of BFI score change after treatment
기간: 2 years
|
Brief Fatigue Inventory( BFI)is a nine item scale used to evaluate the intensity of fatigue and the interference of fatigue to normal activities.
The classification of fatigue severity is: Mild fatigue (1-3), Moderate fatigue (4-6) and Severe fatigue (7-10).
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Side effects related to electroacupuncture
기간: 2 years
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Side effects related to electroacupuncture
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2 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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. .