Clinical trial NCT03640195: 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
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
timeFrame: from enrollment to end of treatment at 6 weeks
Secondary outcomes:
measure: Difference between the two groups from Baseline in fatigue on Brief Fatigue Inventory at 6 Weeks
timeFrame: from enrollment to end of treatment at 6 weeks
measure: Difference between the two groups from Baseline in Anxiety and depression on Hospital Anxiety and depression scale
timeFrame: from enrollment to end of treatment at 6 weeks
measure: 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)
timeFrame: from enrollment to end of treatment at 6 weeks
Other outcomes:
Locations:
Study officials:
References:
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.