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Clinical Trial Summary

There are two recruitment methods for this study, which are mainly based on the Co-Principal Investigator Dr. Chih-Jen Huang recommendation of eligible subjects and poster recruitment methods. When the subjects return to the outpatient clinic, those who meet the conditions for admission will be recommended by Dr. Chih-Jen Huang. If they agree to participate in the trial, they will sign the informed consent form, and instruct the subjects to use their mobile phones to scan the QR code of the relevant introduction of the trial first, and complete the test. The first questionnaire measurement before hydrogen inhalation; if the subjects are recruited by the poster, they can contact the host of Tongtong through the QR code on the poster or the contact number, and sign the consent form for the first time during the return visit. Questionnaire measurement.


Clinical Trial Description

This study is a randomized controlled trial, and an experimental group and a waiting list group will be used to verify the interventional effect of hydrogen. For patients diagnosed with head and neck cancer who received radiation therapy or combined chemotherapy (CCRT) and met the inclusion criteria, the study was included after the study description and the consent of the trial were obtained. Investigators will be included, and the subjects will be numbered by the research executor (Co-Principal Investigator), and the number will be handed over to the project host, who will assign the subjects to the experimental group or the control group according to the random case allocation table generated in advance. The manufacturer will install a hydrogen inhalation machine (hydrogen inhalation or air inhalation) at the subject's home and explain the relevant operation methods. The research executor will pay attention to the LINE group on the first day of installation, and obtain the pre-test basic value data through the google form After (baseline data), continuous hydrogen inhalation was performed daily, and four post-test evaluations were performed before the inhalation and on the 1st, 3rd, 7th, and 14th days after the inhalation was started. The control group was inhaled with the same machine, but the gas was only ordinary air, which was used as a placebo control; after the experiment was over, if the moderator of the air inhalation group explained the plan, hydrogen inhalation would be given in the follow-up month for 1 month. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05728112
Study type Interventional
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact YI-TSEN WU, Master
Phone +886-910809542
Email yitsenwu1030@gmail.com
Status Recruiting
Phase N/A
Start date November 23, 2022
Completion date May 30, 2023

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