Head and Neck CancerNCT03640195
Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy
A study testing Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure in people with Head and Neck Cancer, run by Chang Gung Memorial Hospital.
Trial summary
This study was designed to investigate the effect of Acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in Head neck cancer receiving Concurrent Chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 4 Dec 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy
- Must be able to communicate clearly
- Must be above age 20
Who cannot join
- Previous radiotherapy
- History of arrhythmia or use of a pacemaker
- Local swelling or infection over the acupoint area
About this study
Official title: Acupoint Stimulation for Pain Reduction
This study was designed to investigate the effect of Acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in Head neck cancer receiving Concurrent Chemoradiotherapy.
Read the detailed description
Data were collected from 92 participants in northern Taiwan medical center Radiation Outpatient.They are randomly assigned to the experimental group (n=46) with Acupoint stimulation and control group(n=46). Outcomes were assessed according to the pain, Brief fatigue inventory, Hospital anxiety and depression scale, quality of life, five repeated measures was conducted.
- Conditions
- Head and Neck Cancer
- Being tested
- Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressureOther
Experimental group received Acupoint stimulation, Transcutaneous acupoint electrical stimulation20 minutes/weeks, once a week for six consecutive weeks.
The second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3). each point is 1min, 5days/week, 3 times/day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Transcutaneous nerve electrical stimulation and Auricular acupressure. Receives: Other: Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure |
| Control group | No intervention | without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Pain intensity was assessed using visual analogue scales (VAS) , which is a 10-cm continuous line to assess the subjective perception of pain in the case, with a score of 0 on the leftmost end of the line indicating "painless" and 10 points indicating The "most severe pain" and the reliability of pain assessment , and all participants received this linear tool measurement, recording a total of five
Measured: from enrollment to end of treatment at 6 weeks
Secondary outcomes (3)
Difference between the two groups from Baseline in fatigue on Brief Fatigue Inventory at 6 Weeks
Fatigue is using the friction fatigue inventory (BFI) ; it is a nitrate-item self-reported for measuring fatigue intensity and interference with functionality. Item 1-3 describes the fatigue strength, during The past 24 hour using a visual analogue scale (VAS) ranging from 0 (no fatigue) to 10 (very severely fatigued). Item 4-9 describes interferes with certain functions such as daily activity, including work, walking ability, normal work, Relations with others, and enjoyment in life. Each item was rated on a scale of 0 (does not interfere) to 10 (completely interferes). Its average score for each item indicates its severity of fatigue 1-3 points of helpful mild fatigue, 4 -6 is divided into moderate, 7-10 is divided into severe fatigue.
Measured: from enrollment to end of treatment at 6 weeks
Difference between the two groups from Baseline in Anxiety and depression on Hospital Anxiety and depression scale
The Hospital Anxiety and depression scale (HADS) is composed of two seven-item subscales, one specifically targeting anxiety (HADS-A) and the other focusing on depression (HADS-D). The HADS is a 14-item measure divided into 2 subscales (anxiety and depression), HADS_A and HADS_D are scored separately, the topic arrangement is staggered, and the reverse problem is scored in reverse. The total score is between 0-21 points. Below 8 points means no anxiety and depression; 8 to 10 points may be anxiety and depression. And anxiety and depression of 10 points or more
Measured: from enrollment to end of treatment at 6 weeks
Difference between the two groups from Baseline in quality of life European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H & N 35)
European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H \& N 35) is a specific questionnaire developed by the European Organisation for Research and Treatment of Cancer for head and neck cancer. The module includes 35 questions Assessing symptoms and side effects of treatment, social function and body image/sexuality .This scale includes seven symptoms subscales that measure pain, swallowing, senses problems, speech problems, trouble with social eating, trouble with social Contact, and less sexuality, and also has 11 subscales related with teeth, opening mouth, dry mouth, sticky saliva, coughing, ill feeling, weight loss, weight gain, use of painkillers, nutritional supplements, and feeding tubes. Standardize the original scores, with scores ranging from 0 to 100, with higher scores representing more serious problems.
Measured: from enrollment to end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Oct 2016
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention is divided into two parts: part of The Experimental group received Transcutaneous acupoint electrical stimulation 20 minutes/weeks, the acupoints are unilateral Hegu (LI4) and LU7; This study used Transcutaneous nerve electrical stimulation , 20 minutes each time, once a week for six consecutive weeks. The second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3).A seeds embedding method with seeds attached to the four sides of the unilateral ear, using the thumb and forefinger to apply pressure, the participants will feel sour, each point is 1min, 5days/week, 3 times/day. Control group: without intervention
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640195
- Sponsor's protocol ID
- yahe7693
- Status last verified
- May 2018
- First submitted
- 11 Jul 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chou YH, Yeh ML, Huang TS, Hsu H. Acupoint stimulation improves pain and quality of life in head and neck cancer patients with chemoradiotherapy: A randomized controlled trial. Asia Pac J Oncol Nurs. 2021 Dec 25;9(1):61-68. doi: 10.1016/j.apjon.2021.11.002. eCollection 2022 Jan.
PubMed 35528798
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupoint Stimulation for Pain Reduction
- ClinicalTrials.gov ID
- NCT03640195
- Acronym / sponsor ID
- yahe7693
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 21 Aug 2018 (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.
This study was designed to investigate the effect of Acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in Head neck cancer receiving Concurrent Chemoradiotherapy.
Detailed description
Data were collected from 92 participants in northern Taiwan medical center Radiation Outpatient.They are randomly assigned to the experimental group (n=46) with Acupoint stimulation and control group(n=46). Outcomes were assessed according to the pain, Brief fatigue inventory, Hospital anxiety and depression scale, quality of life, five repeated measures was conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention is divided into two parts: part of The Experimental group received Transcutaneous acupoint electrical stimulation 20 minutes/weeks, the acupoints are unilateral Hegu (LI4) and LU7; This study used Transcutaneous nerve electrical stimulation , 20 minutes each time, once a week for six consecutive weeks. The second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3).A seeds embedding method with seeds attached to the four sides of the unilateral ear, using the thumb and forefinger to apply pressure, the participants will feel sour, each point is 1min, 5days/week, 3 times/day. Control group: without intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressureTranscutaneous nerve electrical stimulation and Auricular acupressure. |
| Control group | No intervention | –without intervention |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy
- Must be able to communicate clearly
- Must be above age 20
Key exclusion criteria (3 listed)
- Previous radiotherapy
- History of arrhythmia or use of a pacemaker
- Local swelling or infection over the acupoint area
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 |
|---|---|---|
| Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressureExperimental group received Acupoint stimulation, Transcutaneous acupoint electrical stimulation20 minutes/weeks, once a week for six consecutive weeks. The second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3). each point is 1min, 5days/week, 3 times/day. | Other | Experimental group |
Primary outcome
Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Time frame: from enrollment to end of treatment at 6 weeks
Pain intensity was assessed using visual analogue scales (VAS) , which is a 10-cm continuous line to assess the subjective perception of pain in the case, with a score of 0 on the leftmost end of the line indicating "painless" and 10 points indicating The "most severe pain" and the reliability of pain assessment , and all participants received this linear tool measurement, recording a total of five
3 secondary outcomes
Difference between the two groups from Baseline in fatigue on Brief Fatigue Inventory at 6 Weeks
Time frame: from enrollment to end of treatment at 6 weeks
Difference between the two groups from Baseline in Anxiety and depression on Hospital Anxiety and depression scale
Time frame: from enrollment to end of treatment at 6 weeks
Difference between the two groups from Baseline in quality of life European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H & N 35)
Time frame: from enrollment to end of treatment at 6 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 21 Aug 2018.
- Derived from this study: PubMed 35528798Chou YH, Yeh ML, Huang TS, Hsu H. Acupoint stimulation improves pain and quality of life in head and neck cancer patients with chemoradiotherapy: A randomized controlled trial. Asia Pac J Oncol Nurs. 2021 Dec 25;9(1):61-68. doi: 10.1016/j.apjon.2021.11.002. eCollection 2022 Jan.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure in people with Head and Neck Cancer, run by Chang Gung Memorial Hospital.
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 3 inclusion and 3 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks (time frame: from enrollment to end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640195, which also lists 1 linked publication.
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 21 Aug 2018.