search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Meridian Electroacupuncture Analysis Device (MEAD)
Sponsored by
Liao Jian An
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Cung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

34 head and neck cancer patients, expected to proceed chemotherapy or radiotherapy in hospital.

Arm Description

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.

Outcomes

Primary Outcome Measures

meridian energy
energy change in meridian

Secondary Outcome Measures

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.
pain degree
use Numerical Rating Scale(0-10) to assess.
Oral mucositis grading
compare enrollment subjects's oral condition with picture from MASCC/ISOO clinical practice guidelines (grade 0-grade 4)
adverse impact on quality of life
use EORTC QLQ - H&N35 questionnaire to evaluate the treatment impact on subject feeling
imaging diagnosis
compare tumor condition in diagnostic image data (shrink or progress) with the energy change in meridian.

Full Information

First Posted
April 27, 2021
Last Updated
September 6, 2023
Sponsor
Liao Jian An
search

1. Study Identification

Unique Protocol Identification Number
NCT04872517
Brief Title
Meridian Energy Changes of Head and Neck Cancer Patients After Chemotherapy or Radiotherapy
Official Title
Detecting Changes Before and After Chemotherapy or Radiotherapy in Patients With Head and Neck Cancer by Meridian Electroacupuncture Analysis Device (MEAD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liao Jian An

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This research will use instruction named MEAD to detect the meridian energy before and after chemotherapy or/and radiotherapy. MEAD is a non-invasive device, it will not inter the conventional treatment that conduct by hematology oncology department and radiation oncology department.
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
34 head and neck cancer patients, expected to proceed chemotherapy or radiotherapy in hospital.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Meridian Electroacupuncture Analysis Device (MEAD)
Intervention Description
use MEAD to detect energy change in patient with head and neck cancer
Primary Outcome Measure Information:
Title
meridian energy
Description
energy change in meridian
Time Frame
An average of 6 weeks
Secondary Outcome Measure Information:
Title
the number of participants with blood test data abnormal
Description
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
Title
pain degree
Description
use Numerical Rating Scale(0-10) to assess.
Time Frame
An average of 6 weeks
Title
Oral mucositis grading
Description
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
Title
adverse impact on quality of life
Description
use EORTC QLQ - H&N35 questionnaire to evaluate the treatment impact on subject feeling
Time Frame
An average of 6 weeks
Title
imaging diagnosis
Description
compare tumor condition in diagnostic image data (shrink or progress) with the energy change in meridian.
Time Frame
An average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. patients with head and neck cancer has not received surgery yet, and will plan to accept chemotherapy and/or radiotherapy. recurrent head and neck cancer, and expect to received chemotherapy and/or radiotherapy. patient with vital sings stableness, conscious clear, and have ability to recognize the contain of trail and sign consent. not accept other adjuvant therapy. no brain metastasis or psychosis, and will to join whole course as well as accept assessments. Exclusion Criteria: Aged less than 20 years old and over 75 years old。 Patients be diagnosed with head and neck cancer, and accepted surgery, or already finished chemotherapy and/or radiotherapy. patient with brain metastasis, conscious unclear, and have not able to recognize the contain of trail and sign consent. Accept other adjuvant therapy and chemotherapy and/or radiotherapy simultaneously. Combined with serious organs failure。 Have contraindication in chemotherapy or radiotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao-Hua Fang
Phone
886-2-24313131
Ext
2501
Email
yihwa0813@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-An Liao
Phone
886-2-24313131
Ext
2501
Email
frank771124@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-An Liao
Organizational Affiliation
medical attending
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Cung Memorial Hospital
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao-Hua Fang
Phone
886-2-243-13131
Ext
2501
Email
yihwa0813@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs