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临床试验/NCT05094310
NCT05094310Unknown不适用

Genetic Predictors of Response to Acupuncture for Cancer-related Fatigue Among Breast Cancer Patients After Chemotherapy

Affiliated Hospital of Qinghai University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Difference of BFI score change after treatment

研究概览

简要总结

Genetic predictors of response to acupuncture for cancer-related fatigue among breast cancer patients after chemotherapy.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Difference of BFI score change after treatment

时间窗: 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).

次要结局

  • Side effects related to electroacupuncture(2 years)

研究者

发起方
Affiliated Hospital of Qinghai University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiuda Zhao

Professor

Affiliated Hospital of Qinghai University

研究点 (1)

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