An interventional study of Meridian Electroacupuncture Analysis Device (MEAD) in Head and Neck Cancer, sponsored by Liao Jian An. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Liao Jian An · Not applicable, Interventional, and Diagnostic
This trial is conducted by using MEAD to detect the meridian changes in patients with head and neck cancer after conventional treatment of chemotherapy or radiotherapy.
The purpose of this research is observe the change of meridian energy in patients have be diagnosed with head and neck cancer. The instrument we use is a non-invasive device called meridian energy analysis device(MEAD). The theory of MEAD is use conductive rod to measure the skin resistance from the specific point in human body, and to calculate the meridian's energy change. In Traditional Chinese Medicine theory, physician doctor believe that the median in human body would be affected by disease or uncomfortable condition. So, this time, we who a group of physician of Traditional Chinese medicine department conduct this research to assess the energy change in patients with head and neck cancer. The trail cooperate with radiation oncology department and hematology oncology department. Subject enrollment from radiation oncology department and hematology Oncology department. All of subjects have be diagnosed with head and neck cancer, and will to receive conventional treatment, no matter chemotherapy or/and radiotherapy.
The major assessment of our research is meridian energy by MEAD before treatment, and six consecutive cycles. In addition to this, pain degree, oral mucositis condition, impact on life quality, and blood test, diagnosis imaging data will be collected.
According to G*Power( 3.1.9.4 edition), we expected to recruit 34 subjects. All of Statistical Analysis will use SPSS, pair-t test is used to analyze continuous variable, categorical variable will be analyzed by Chi-Square Test. Multivariate regression analysis will be apply to discuss the major factor of the meridian changes.
MEAD is a kind of non-invasive device, hasn't had adverse effect until now. We will start emergency handling If accidents happened within measurement.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 34 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →This is the only study on the registry with Liao Jian An as lead sponsor.
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Exclusion Criteria:
Total 34 anticipants will recruit in this research. Age was limited between 20years old to 75 years old. All of anticipants agree to join this trail and be followed through treatment , and without underlying disease that threaten life.
Device: Meridian Electroacupuncture Analysis Device (MEAD)
use MEAD to detect energy change in patient with head and neck cancer
meridian energy
energy change in meridian
Time frame: An average of 6 weeks
the number of participants with blood test data abnormal
calculate the ratio of participants in hemodynamic alteration whom accept chemotherapy or/and radiotherapy, and compare the hemodynamic change with meridian energy change. Blood test include CBC/DC (WBC, RBC, Hemoglobin, Hematocrit, platelets, segment, lymphocyte, absolutely neutrophil), GOT/GPT, Bun/Creatinine, Bilirubin.
Time frame: An average of 6 weeks
pain degree
use Numerical Rating Scale(0-10) to assess.
Time frame: An average of 6 weeks
Oral mucositis grading
compare enrollment subjects's oral condition with picture from MASCC/ISOO clinical practice guidelines (grade 0-grade 4)
Time frame: An average of 6 weeks
adverse impact on quality of life
use EORTC QLQ - H\&N35 questionnaire to evaluate the treatment impact on subject feeling
Time frame: An average of 6 weeks
imaging diagnosis
compare tumor condition in diagnostic image data (shrink or progress) with the energy change in meridian.
Time frame: An average of 6 weeks
Plan to share: No
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