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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04872517
• Other study ID #: 202100209B0C501
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: Chao-Hua Fang
• Phone: 886-2-24313131
• Email: yihwa0813[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• Meridian Electroacupuncture Analysis Device (MEAD)
use MEAD to detect energy change in patient with head and neck cancer

Locations

Country	Name	City	State
Taiwan	Chang Cung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Liao Jian An

Country where clinical trial is conducted

Taiwan, 

Outcome

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