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

NCT04872517 | Unknown

• 1 other identifier: 202100209B0C501
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• meridian energy

  energy change in meridian

  An average of 6 weeks

Secondary Outcomes (5)

• the number of participants with blood test data abnormal

  An average of 6 weeks

• pain degree

  An average of 6 weeks

• Oral mucositis grading

  An average of 6 weeks

• adverse impact on quality of life

  An average of 6 weeks

• imaging diagnosis

  An average of 6 weeks

Study Arms (1)

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

EXPERIMENTAL

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)

Interventions

Meridian Electroacupuncture Analysis Device (MEAD) DEVICE

use MEAD to detect energy change in patient with head and neck cancer

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liao Jian An: lead

Study Sites (1)

Chang Cung Memorial Hospital

Keelung, 20401, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jian-An Liao

  medical attending

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Hua Fang

CONTACT

886-2-24313131; yihwa0813@yahoo.com.tw

Jian-An Liao

CONTACT

886-2-24313131; frank771124@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician of Traditional Chinese Medicine department

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 4, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)