Condition category
Mental and Behavioural Disorders
Date applied
07/05/2018
Date assigned
10/05/2018
Last edited
09/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes