Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy
- Must be able to communicate clearly
- Must be above age 20
Exclusion Criteria:
- Previous radiotherapy
- History of arrhythmia or use of a pacemaker
- Local swelling or infection over the acupoint area
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Transcutaneous nerve electrical stimulation and Auricular acupressure.
without intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT03640195
First Posted
July 11, 2018
Last Updated
August 17, 2018
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03640195
Brief Title
Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy
Official Title
Acupoint Stimulation for Pain Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Transcutaneous nerve electrical stimulation and Auricular acupressure.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
without intervention
Intervention Type
Other
Intervention Name(s)
Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Description
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
Time Frame
from enrollment to end of treatment at 6 weeks
Secondary Outcome Measure Information:
Title
Difference between the two groups from Baseline in fatigue on Brief Fatigue Inventory at 6 Weeks
Description
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.
Time Frame
from enrollment to end of treatment at 6 weeks
Title
Difference between the two groups from Baseline in Anxiety and depression on Hospital Anxiety and depression scale
Description
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
Time Frame
from enrollment to end of treatment at 6 weeks
Title
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)
Description
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.
Time Frame
from enrollment to end of treatment at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy
Must be able to communicate clearly
Must be above age 20
Exclusion Criteria:
Previous radiotherapy
History of arrhythmia or use of a pacemaker
Local swelling or infection over the acupoint area
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35528798
Citation
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. Erratum In: Asia Pac J Oncol Nurs. 2023 Mar 28;10(4):100208.
Results Reference
derived
Learn more about this trial
Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy
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