DysgeusiaNCT05868850
Application of Auricular Point Sticking in Patients With Taste Alteration
A study testing auricular point sticking in people with Dysgeusia and Acupressure, run by Affiliated Hospital of Jiangnan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysgeusia, Acupressure, Chemotherapy Effect
- What is being tested?
- auricular point sticking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study On The Application of Auricular Point Sticking Based On Holographic Theory In Chemotherapy-related Taste Alterations In Cancer Patients
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.
Read the detailed 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.
- Conditions
- Dysgeusia, Acupressure, Chemotherapy Effect
- Being tested
- auricular point sticking
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular point stickingBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Routine care group | No intervention | The control group receives routine nursing, including admission education, routine nursing of adverse reactions to chemotherapy, diet guidance for chemotherapy patients, precautions for various examinations, discharge guidance and follow-up. |
| Auricular point sticking group | Experimental | Auricular point sticking therapy is performed on the basis of control group. The acupoint intervention group is established, and the research team consists of 2 graduate students, 1 graduate supervisor, 1 head nurse, 1 chief physician of traditional Chinese medicine, and 1 nursing expert. The nursing expert is responsible for the overall design of the project, and the director of traditional Chinese medicine is responsible for the selection of acupoints and the training of nurses for massage. The supervisor of graduate students and the head nurse are responsible for the overall quality control of the intervention process, while the graduate students are responsible for the preliminary and final screening of research objects, the implementation of intervention programs, the organization, coordination and recording of the entire intervention process and the collection of data. Receives: Behavioral: auricular point sticking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks.
Secondary outcomes (6)
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.
Measured: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks. T5:8 weeks.
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.
Measured: T1: Baseline. T2:2 weeks. T3:4 weeks. T4:5 weeks. T5:8 weeks.
Nutritional status 1
The nutritional status of patients was evaluated according to their weight.
Measured: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
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.
Measured: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 3
The nutritional status of patients was evaluated according weight loss rate.
Measured: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 4
The nutritional status of patients was evaluated according to their serum total protein and albumin index.
Measured: T1: baseline(Data were collected before the intervention). T2: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start3 Jun 2023
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysgeusiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quan Liu, Doctor, Study chair, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868850
- Sponsor's protocol ID
- 1415322141
- Status last verified
- Jan 2024
- First submitted
- 24 Apr 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study On The Application of Auricular Point Sticking Based On Holographic Theory In Chemotherapy-related Taste Alterations In Cancer Patients
- ClinicalTrials.gov ID
- NCT05868850
- Acronym / sponsor ID
- 1415322141
- Conditions
- Dysgeusia, Acupressure, Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care group | No intervention | –The control group receives routine nursing, including admission education, routine nursing of adverse reactions to chemotherapy, diet guidance for chemotherapy patients, precautions for various examinations, discharge guidance and follow-up. |
| Auricular point sticking group | Experimental | Behavioral: auricular point stickingAuricular point sticking therapy is performed on the basis of control group. The acupoint intervention group is established, and the research team consists of 2 graduate students, 1 graduate supervisor, 1 head nurse, 1 chief physician of traditional Chinese medicine, and 1 nursing expert. The nursing expert is responsible for the overall design of the project, and the director of traditional Chinese medicine is responsible for the selection of acupoints and the training of nurses for massage. The supervisor of graduate students and the head nurse are responsible for the overall quality control of the intervention process, while the graduate students are responsible for the preliminary and final screening of research objects, the implementation of intervention programs, the organization, coordination and recording of the entire intervention process and the collection of data. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular point sticking1. Acupoint selection: Select Shenmen, spleen, stomach, liver, sympathetic, tongue, digestive system under the cortex, three focal, ear-back spleen. 2. 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. 3. 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. | Behavioural | Auricular point sticking group |
Primary outcome
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.
6 secondary outcomes
Quality of life for cancer patients
Time frame: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks. T5:8 weeks.
Anxiety and depression
Time frame: T1: Baseline. T2:2 weeks. T3:4 weeks. T4:5 weeks. T5:8 weeks.
Nutritional status 1
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 2
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 3
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.
Nutritional status 4
Time frame: T1: baseline(Data were collected before the intervention). T2: 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
Related trials for Dysgeusia
Recruiting
A Study of Freeze-Dried Miracle Fruit (MiraBurst) on Participants Receiving Cancer Treatment
Dysgeusia, Solid Tumor
Recruiting
Taste Alterations Study
Chemotherapy Side Effects, Taste, Altered
Not yet recruiting
Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Recruiting
Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention
Multiple Myeloma (MM), GI Cancer
Recruiting
Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
Chemotherapy-Related Taste Alteration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quan Liu, Doctor study chair
Affiliated Hospital of Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular point sticking in people with Dysgeusia and Acupressure, run by Affiliated Hospital of Jiangnan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste alterations (time frame: T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.