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Trial Title:
Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients
NCT ID:
NCT05728112
Condition:
Head and Neck Cancer
Quality of Life
Pain
Sleep
Inhalation; Gas
Conditions: Official terms:
Head and Neck Neoplasms
Respiratory Aspiration
Conditions: Keywords:
Head and Neck Cancer
Hydrogen
Cancer related symptom
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
Hydrogen Inhalation
Description:
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.
Arm group label:
Hydrogen Inhalation
Intervention type:
Other
Intervention name:
Ordinary Air Inhalation
Description:
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.
Arm group label:
Ordinary Air Inhalation
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807378
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Pi-Ling Chou, PHD
Phone:
886-7-3121101
Phone ext:
2610
Email:
piling.chou@gmail.com
Start date:
November 23, 2022
Completion date:
May 30, 2023
Lead sponsor:
Agency:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
OTA HYDROGEN SOLUTIONS LTD.
Agency class:
Other
Source:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05728112
