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NCT Number: NCT05868850

Application of Auricular Point Sticking in Patients With Taste Alteration

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.

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Key information

Conditions

Dysgeusia Acupressure Chemotherapy Effect Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Taste Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

auricular point sticking

Behavioral
  • 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.

Primary outcomes

  1. Taste alterations

    Time frame: 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.

Secondary outcomes

  1. Quality of life for cancer patients

    Time frame: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks. T5:8 weeks.

    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.

  2. Anxiety and depression

    Time frame: T1: Baseline. T2:2 weeks. T3:4 weeks. T4:5 weeks. T5:8 weeks.

    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.

  3. Nutritional status 1

    Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.

    The nutritional status of patients was evaluated according to their weight.

  4. Nutritional status 2

    Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.

    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.

  5. Nutritional status 3

    Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.

    The nutritional status of patients was evaluated according weight loss rate.

  6. Nutritional status 4

    Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks.

    The nutritional status of patients was evaluated according to their serum total protein and albumin index.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiangnan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 22, 2023
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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