Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

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,

Trial website

Contact information



Primary contact

Dr Li Tian


Contact details

No. 188 Shizi street
+86 512 65221481

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Auricular acupressure for cancer-related fatigue, sleep disturbance and anxiety in lung cancer patients undergoing chemotherapy


Study hypothesis

Auricular acupressure (AA) can alleviate cancer-related fatigue, sleep disturbance and anxiety in lung cancer patients

Ethics approval

Ethics Committee of the First Affiliated Hospital of Soochow University, 03/03/2017, 2017028

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.


Fatigue, sleep disturbance and anxiety in lung cancer patients with no severe complications


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



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Total final enrolment


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

First Affiliated hospital of Soochow University
No. 188 Shizi street

Sponsor information


Suzhou Municipal Science and Technology Bureau

Sponsor details

No. 979 Renming Road
+ 86 512 65241084

Sponsor type




Funder type

Not defined

Funder name

Suzhou Science and Technology Development Project (SYS 201526)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 results in (added 23/11/2020)

Publication citations

Additional files

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.