Application of Auricular Point Sticking in Patients With Taste Alteration

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05868850
• Other study ID #: 1415322141
• Status: Completed
• Phase: N/A
• Start date: June 3, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Affiliated Hospital of Jiangnan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients with malignant tumors diagnosed by histopathology or pathology;

2. Age =18 years old;

3. Patients who received platinum-based chemotherapy and completed at least one cycle of chemotherapy;

4. According to the chemotherapy-induced taste Changes Scale (CiTAS), the score of patients was =6;

5. Patients voluntarily participated in the treatment with good compliance and adherence.

Exclusion Criteria:

1. Patients with treatment plan adjustment or concurrent radiotherapy;

2. Patients with abnormal taste and malnutrition caused by various reasons before chemotherapy;

3. Patients with inflammation of the external ear or eczema, ulcers, chilblain in the pressing area;

4. Allergic or intolerant to adhesive stickers;

5. Those who were lost to follow-up or withdrew voluntarily;

6. Patients enrolled in other studies at the same time.

Related Conditions & MeSH terms

• Acupressure
• Chemotherapy Effect
• Dysgeusia

Intervention

Behavioral:
• auricular point sticking
Acupoint selection: Select Shenmen, spleen, stomach, liver, sympathetic, tongue, digestive system under the cortex, three focal, ear-back spleen. Operation: Use 75% ethanol to disinfect auricular broad skin; To be dry, use tweezers to pick up the middle of the small square tape stuck with Wang do not line seeds, align the indentation and stick well, press gently with the finger abdomen, the strength to the patient feel acid swelling, pain and heat sense and can tolerate it. Press frequency and course of treatment: it is asked to press 4 times a day, once in the morning, middle and evening before going to bed, 3-5 minutes each time, the duration of hospitalization for patients with chemotherapy is generally 3-5 days, intervention begins on the first day of chemotherapy medication, the day of discharge for patients to replace the other side of the ear acupoint, removed after 4 days of discharge. A total of 2 chemotherapy courses were treated.

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taste alterations	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.	T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks.
Secondary	Quality of life for cancer patients	With the use of the European Organization for Research on Treatment of Cancer, the most widely used guideline in clinical practice, The EORTC Quality of Life Core Questionnaire (QLQ-C30) was used to evaluate the quality of life of patients.A total of 30 items and 15 domains were included, including 5 functional domains, 9 symptom domains and 1 general health/quality of life domain. Among them, the general health status/quality of life domain was divided into 7 grades, which were calculated from 1 to 7 points according to the answer options. Other items were on a 4-point scale, and "never", "a little", "a lot" and "a lot" were scored from 1 to 4 respectively. The domain score was obtained by summing the item scores included in each domain and dividing by the number of items included, ranging from 0 to 100. A lower score indicates a better quality of life.	T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks. T5:8 weeks.
Secondary	Anxiety and depression	The Chinese version of Hospital Anxiety and Depression Scale (HADS) was used to assess the anxiety and depression level of patients. There were 14 items in total, including 7 items for anxiety and 7 items for depression. Each item was scored from 0 to 3, with a minimum score of 0 and a maximum score of 42, and the higher the score, the more serious the level of anxiety and depression.	T1: Baseline. T2:2 weeks. T3:4 weeks. T4:5 weeks. T5:8 weeks.
Secondary	Nutritional status 1	The nutritional status of patients was evaluated according to their weight.	T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Secondary	Nutritional status 2	The nutritional status of patients was evaluated according to their BMI.BMI= weight (in kilograms) divided by the square of height (in meters). The standard of BMI for Chinese adult residents is about 18.4, less than or equal to 18.4 is thin, 18.5 to 23.9 is normal, 24 to 27.9 is overweight, and more than or equal to 28 is obese.	T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Secondary	Nutritional status 3	The nutritional status of patients was evaluated according weight loss rate.	T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Secondary	Nutritional status 4	The nutritional status of patients was evaluated according to their serum total protein and albumin index.	T1: baseline(Data were collected before the intervention). T2: 4 weeks.