Clinical trial NCT04872517: 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
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: meridian energy
timeFrame: An average of 6 weeks
Secondary outcomes:
measure: the number of participants with blood test data abnormal
timeFrame: An average of 6 weeks
measure: pain degree
timeFrame: An average of 6 weeks
measure: Oral mucositis grading
timeFrame: An average of 6 weeks
measure: adverse impact on quality of life
timeFrame: An average of 6 weeks
measure: imaging diagnosis
timeFrame: An average of 6 weeks
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Cung Memorial Hospital
Study officials:
affiliation: medical attending
name: Jian-An Liao
role: PRINCIPAL_INVESTIGATOR
References: