Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2023-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer Quality of Life Pain Sleep Inhalation; Gas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hydrogen Inhalation

The manufacturer installs the hydrogen inhalation machine at the subject's home and explains the relevant operation methods. The research executor will take care of it in the LINE group on the first day of installation, and after obtaining the pre-test baseline data (baseline data) through the google form, carry out each test. Continuous inhalation of hydrogen was carried out every day, and four post-test assessments were performed before inhalation and on the 1st, 3rd, 7th, and 14th days after inhalation.

Group Type EXPERIMENTAL

Hydrogen Inhalation

Intervention Type OTHER

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.

Ordinary Air Inhalation

This group used the same model to inhale, but the gas released was only ordinary air, as a placebo control.

Group Type PLACEBO_COMPARATOR

Ordinary Air Inhalation

Intervention Type OTHER

The control group was inhaled with the same machine as the experimental group, but the gas was only ordinary air, which was used as a placebo control.

Interventions

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Hydrogen Inhalation

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.

Intervention Type OTHER

Ordinary Air Inhalation

The control group was inhaled with the same machine as the experimental group, but the gas was only ordinary air, which was used as a placebo control.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults over the age of 20
* Pathological diagnosed with head and neck cancer
* Received radiation therapy or combined chemotherapy
* Can use Mandarin or Taiwanese to communicate and have normal cognition

Exclusion Criteria

* With chronic obstructive pulmonary disease
* Having contraindications to use of low flow oxygen
* Feeling uncomfortable using nasal cannula for inhalation

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No