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临床试验/NCT05868850
NCT05868850已完成不适用

Study On The Application of Auricular Point Sticking Based On Holographic Theory In Chemotherapy-related Taste Alterations In Cancer Patients

Affiliated Hospital of Jiangnan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Taste alterations

研究概览

简要总结

To explore the intervention effect of auricular point sticking on chemotherapy-induced taste alterations in cancer patients, and analyze its relationship with quality of life, nutritional status and psychology of patients.

详细描述

Taste alteration is a common adverse reaction in patients with chemotherapy. The incidence of taste alteration varies with chemotherapy drugs, ranging from 36% to 84%, among which platinum chemotherapeutic drugs are most likely to cause severe taste alteration. The taste alteration does not pose a serious threat to the life of patients, so it is often ignored by patients and medical staff. Dysgeusia is positively correlated with the loss of appetite, which can directly lead to the loss of appetite and insufficient intake of nutrients in patients, and even stimulate patients' anxiety, psychological pain and other negative emotions. In severe cases, it can cause malnutrition, reduce the chemotherapy compliance of cancer patients, and ultimately reduce the quality of life of patients. Therefore, for patients with platinum chemotherapy, it is necessary to pay close attention to the change of taste during chemotherapy, and apply effective nursing interventions to pay attention as soon as possible, so as to improve the quality of life of patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with malignant tumors diagnosed by histopathology or pathology;
  • Age ≥18 years old;
  • Patients who received platinum-based chemotherapy and completed at least one cycle of chemotherapy;
  • According to the chemotherapy-induced taste Changes Scale (CiTAS), the score of patients was ≥6;
  • Patients voluntarily participated in the treatment with good compliance and adherence.

排除标准

  • Patients with treatment plan adjustment or concurrent radiotherapy;
  • Patients with abnormal taste and malnutrition caused by various reasons before chemotherapy;
  • Patients with inflammation of the external ear or eczema, ulcers, chilblain in the pressing area;
  • Allergic or intolerant to adhesive stickers;
  • Those who were lost to follow-up or withdrew voluntarily;
  • Patients enrolled in other studies at the same time.

结局指标

主要结局

Taste alterations

时间窗: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks.

The Chinese version of the Chemotherapy-induced Taste Alteration Scale (CiTAS), was used to assess the patients' taste alterations. The scale has 18 items in three dimensions, namely taste alteration, unpleasant taste alteration, unpleasant symptoms and problems. The scale is a Like-5 scale with a minimum score of 18 and a maximum score of 90, with higher scores indicating more severe symptoms of taste alterations. The scale has been verified by research and has good reliability and validity.

次要结局

  • Nutritional status 2(T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.)
  • Quality of life for cancer patients(T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks. T5:8 weeks.)
  • Anxiety and depression(T1: Baseline. T2:2 weeks. T3:4 weeks. T4:5 weeks. T5:8 weeks.)
  • Nutritional status 1(T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.)
  • Nutritional status 3(T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.)
  • Nutritional status 4(T1: baseline(Data were collected before the intervention). T2: 4 weeks.)

研究者

发起方
Affiliated Hospital of Jiangnan University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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