Acupressure of the ear for fatigue, sleep problems and anxiety in cancer patients treated with chemotherapy
| ISRCTN | ISRCTN16408424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16408424 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/05/2018
- Registration date
- 10/05/2018
- Last edited
- 23/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cancer-related fatigue (CRF) is common in lung cancer patients treated with chemotherapy and this can affect the patient's quality of life. Auricular acupressure (stimulating acupuncture points on the ear without using needles or breaking the skin) has been increasingly used to manage symptoms in cancer patients.
Who can participate?
People aged 18-75 years who are receiving chemotherapy (drug treatment) for lung cancer
What does the study involve?
In the two intervention groups, patients will have a small ball-shaped seed or a magnetic ball taped to five acupressure points on their ear. They will press each seed or ball against the ear 4 to 6 times per session at 5 sessions per day. They will do this every day for 18 days to complete a cycle of therapy. They will have 3 days with no seed or balls taped to their ear before starting the next 18-day course. There are 3 18-days courses in the study. Patients in the control group will receive the usual care for lung cancer patients treated with chemotherapy.
What are the possible benefits and risks of participating?
There are no side effects linked with auricular acupressure reported previous studies. Participants will receive a certain amount of compensation for their time.
Where is the study run from?
First Affiliated Hospital of Soochow University
When is the study starting and how long is it expected to run for?
December 2016 to August 2018
Who is funding the study?
Suzhou Municipal Science and Technology Bureau
Who is the main contact?
Dr Tian Li, tianlisz@suda.edu.cn
Contact information
Scientific
No. 188 Shizi street
suzhou
215006
China
| Phone | +86 512 65221481 |
|---|---|
| tianlisz@suda.edu.cn |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Auricular acupressure for cancer-related fatigue, sleep disturbance and anxiety in lung cancer patients undergoing chemotherapy |
| Study objectives | Auricular acupressure (AA) can alleviate cancer-related fatigue, sleep disturbance and anxiety in lung cancer patients |
| Ethics approval(s) | Ethics Committee of the First Affiliated Hospital of Soochow University, 03/03/2017, 2017028 |
| Health condition(s) or problem(s) studied | Fatigue, sleep disturbance and anxiety in lung cancer patients with no severe complications |
| Intervention | Those patients who met the study criteria were randomly assigned to one of three groups using computer-generated numbers. Group A: auricular acupressure using Semen Vaccariae (SV, seed of cowherb [Vaccaria segetalis]) Disinfect the skin with 75% alcohol, dry the skin, and place a piece of tape with SV on the selected ear acupoint. Vertically press the SV until the patients report the feeling of swelling pain, continue to press each acupoint for 20 to 30 seconds, and press the five selected acupoints repeatedly and in turn 4 to 6 times for each session, with 5 sessions per day (i.e., in the morning, after each of 3 meals and before bedtime). Replace the SV tape every 3 days. One treatment course included six replacements, the interval between two consecutive treatment courses was three days, and the whole intervention length of the study was three treatment courses, i.e. three cycles of therapy. Group B: auricular acupressure using magnetic beads The intervention protocols for group B and group A were the same; the only difference was that magnetic beads were used in group B in place of SV. Group C: routine care Patients received routine care during hospitalization, and after discharge, regular telephone follow-up and home visits were performed. |
| Intervention type | Other |
| Primary outcome measure | Cancer-related fatigue (CRF) was assessed by the Cancer Fatigue Scale - Chinese version (CFS-C) using a numerical rating scale ranging from 0 to 10, with 10 indicating severe CRF and ≥4 indicating clinically significant fatigue. CRF was measured at baseline and at the end of the whole intervention, i.e. after the patients received three cycles of therapy. |
| Secondary outcome measures | 1. Sleep quality and quantity in the past month was assessed using the Pittsburgh Sleep Quality Index (PSQI) 2. Anxiety was assessed using the Self-rating Anxiety Scale (SAS) Sleep disturbance and anxiety were measured at baseline and at the end of the whole intervention, i.e. after the patients received three cycles of therapy. |
| Overall study start date | 01/12/2016 |
| Completion date | 31/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 18-75 years 2. Receiving conventional chemotherapy for lung cancer 3. Diagnosed with CRF using the diagnostic standards of the International Statistical Classification of Diseases and Related Health Problems 10th Revision and showed CRF ≥4 on a 0-10 numerical rating scale 4. No infection, injury or ulcers around the acupoint 5. No previous participation in AA or any fatigue-related intervention 6. No cognitively impairment 7. Willing to participate |
| Key exclusion criteria | Patients who had pleural effusion and other severe complications (such as severe anemia, severe organic diseases or dysfunction of heart, brain, or kidney) were excluded |
| Date of first enrolment | 01/12/2016 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- China
Study participating centre
suzhou
215006
China
Sponsor information
Government
No. 979 Renming Road
suzhou
215002
China
| Phone | + 86 512 65241084 |
|---|---|
| szkjxm@szkj.gov.cn | |
"ROR" |
https://ror.org/02vpk4745 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2021 | 23/11/2020 | Yes | No |
Editorial Notes
23/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
