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, tianlisz@suda.edu.cn
Trial website
Contact information
Type
Scientific
Primary contact
Dr Li Tian
ORCID ID
Contact details
No. 188 Shizi street
suzhou
215006
China
+86 512 65221481
tianlisz@suda.edu.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Auricular acupressure for cancer-related fatigue, sleep disturbance and anxiety in lung cancer patients undergoing chemotherapy
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Phase
Drug names
Primary outcome measures
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
01/12/2016
Overall trial end date
31/08/2017
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
75
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
01/12/2016
Recruitment end date
30/06/2017
Locations
Countries of recruitment
China
Trial participating centre
First Affiliated hospital of Soochow University
No. 188 Shizi street
suzhou
215006
China
Sponsor information
Organisation
Suzhou Municipal Science and Technology Bureau
Sponsor details
No. 979 Renming Road
suzhou
215002
China
+ 86 512 65241084
szkjxm@szkj.gov.cn
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
Suzhou Science and Technology Development Project (SYS 201526)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
31/08/2018
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary