Meridian Energy Changes of Head and Neck Cancer Patients After Chemotherapy or Radiotherapy

Detecting Changes Before and After Chemotherapy or Radiotherapy in Patients With Head and Neck Cancer by Meridian Electroacupuncture Analysis Device (MEAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: Meridian Electroacupuncture Analysis Device (MEAD)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao-Hua Fang; Phone Number: 2501 886-2-24313131; Email: yihwa0813@yahoo.com.tw
• Study Contact Backup: Name: Jian-An Liao; Phone Number: 2501 886-2-24313131; Email: frank771124@hotmail.com

Study Locations

• Taiwan
  • Keelung, Taiwan, 20401
    • Recruiting
    • Chang Cung Memorial Hospital
    • Contact: Chao-Hua Fang; Phone Number: 2501 886-2-243-13131; Email: yihwa0813@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. patients with head and neck cancer, included nasopharyngeal carcinoma, laryngeal cancer, oropharyngeal cancer, ear and oral cancer, hypopharyngeal cancer, salivary-gland carcinoma. Aged between 20 years old to 75years old, no gender difference.
2. patients with head and neck cancer has not received surgery yet, and will plan to accept chemotherapy and/or radiotherapy.
3. recurrent head and neck cancer, and expect to received chemotherapy and/or radiotherapy.
4. patient with vital sings stableness, conscious clear, and have ability to recognize the contain of trail and sign consent.
5. not accept other adjuvant therapy.
6. no brain metastasis or psychosis, and will to join whole course as well as accept assessments.

Exclusion Criteria:

1. Aged less than 20 years old and over 75 years old。
2. Patients be diagnosed with head and neck cancer, and accepted surgery, or already finished chemotherapy and/or radiotherapy.
3. patient with brain metastasis, conscious unclear, and have not able to recognize the contain of trail and sign consent.
4. Accept other adjuvant therapy and chemotherapy and/or radiotherapy simultaneously.
5. Combined with serious organs failure。
6. Have contraindication in chemotherapy or radiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 34 head and neck cancer patients, expected to proceed chemotherapy or radiotherapy in hospital.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
meridian energy	energy change in meridian	An average of 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	An average of 6 weeks
pain degree	use Numerical Rating Scale(0-10) to assess.	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)	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	An average of 6 weeks
imaging diagnosis	compare tumor condition in diagnostic image data (shrink or progress) with the energy change in meridian.	An average of 6 weeks

Collaborators and Investigators

• Sponsor: Liao Jian An
• Investigators: Principal Investigator: Jian-An Liao, medical attending

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 202100209B0C501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No