Head and Neck CancerhydrogenNCT05728112
Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients
A study testing Hydrogen Inhalation and Ordinary Air Inhalation in people with Head and Neck Cancer and Quality of Life, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Head and Neck Cancer, Quality of Life, Pain
- What is being tested?
- Hydrogen Inhalation and Ordinary Air Inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- With chronic obstructive pulmonary disease
- Having contraindications to use of low flow oxygen
- Feeling uncomfortable using nasal cannula for inhalation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807378
Pi-Ling Chou, PHD, 886-7-3121101 ext. 2610, piling.chou@gmail.com
About this study
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Quality of Life, Pain, Sleep, Inhalation; Gas
- Being tested
- Hydrogen Inhalation, Ordinary Air Inhalation
- Keywords
- Head and Neck Cancer, Hydrogen, Cancer related symptom
- Medical subject headings
- Head and Neck Neoplasms, Pain, Respiratory Aspiration, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen InhalationOther
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 InhalationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen Inhalation | Experimental | 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. Receives: Other: Hydrogen Inhalation |
| Ordinary Air Inhalation | Placebo comparator | This group used the same model to inhale, but the gas released was only ordinary air, as a placebo control. Receives: Other: Ordinary Air Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline MDASI-Taiwan Form at 3rd days, 7th days, 14th days
Using MDASI-Taiwan Form: Divided into two parts, the severity of symptom distress and the degree of interference with life, a total of 19 questions, each question is scored from 0 to 10, 0 is no trouble, 10 is the most serious, and the average score after the evaluation is ≥4 Points indicate significant symptom distress.
Measured: Baseline, 3rd days, 7th days, 14th days
Change from Baseline VSH sleep scale at 3rd days, 7th days, 14th days
Using Verran and Snyder-Halpern Sleep Scale(VSH sleep scale): It is divided into three subscales of sleep disturbance, effective sleep and compensatory sleep, with a total of 15 items. Using the visual analog measurement method using a 10 cm horizontal line, patients are asked to self-evaluate their feelings about sleep the night before and then evaluate their sleep patterns. There are 8 forward questions and 7 reverse questions in the questions. The minimum score for each forward question is 0 and the highest is 100 points. The opposite is true for the reverse questions. The overall sleep quality score is the sum of the total scores of the three subscales. In total, the total score ranges from 0 to 1500, with lower scores indicating poorer sleep quality.
Measured: Baseline, 3rd days, 7th days, 14th days
Change from Baseline BFI-Taiwan Form at 3rd days, 7th days, 14th days
Using Brief Fatigue Inventory-Taiwanese (BFI-Taiwan Form): It is divided into five major items and nine sub-questions, including: whether there is unusual fatigue or fatigue in a week, the current level of fatigue, the general level of fatigue in the past 24 hours, the most fatigued level in the past 24 hours, and the impact of fatigue on life in the past 24 hours Level of influence, including: general activities, mood, ability to walk, normal work, relationships with others, enjoyment of life, etc. Each question is scored from 0 to 10, with 0 being no distress and 10 being the most serious, and the average of the scores after evaluation is ≥ 4, indicating significant symptom distress.
Measured: Baseline, 3rd days, 7th days, 14th days
Change from Baseline European Quality of Life Scal-Five Dimensions Questionnaire (EQ-5D or EuroQOL) at 3rd days, 7th days, 14th days
Using EQ-5D: It is composed of two parts. In the first part, the subjects need to answer the health status of the day, including five questions: action, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question has three options: "no problem", "some problem/moderate problem", "incapable of self-care/extreme problem", which can be weighted to get a single score. Five oriented questions can obtain 243 different health states, and through the group standard reference value established by time trade-off (TTO), a single EQ-5D score can be obtained after weighting (EQ-index ). The raw score on the EQ-5D was converted from -0.549 to 1, where 1 indicates "best state" quality of life, 0 indicates "death", and values below 0 indicate a state "worse than death".
Measured: Baseline, 3rd days, 7th days, 14th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start23 Nov 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- OTA HYDROGEN SOLUTIONS LTD.
- Responsible party
- Sponsor
- Investigators
- YI-TSEN WU, Master, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728112
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210097
- Acronym
- hydrogen
- Status last verified
- Oct 2022
- First submitted
- 5 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients
- ClinicalTrials.gov ID
- NCT05728112
- Acronym / sponsor ID
- hydrogen / KMUHIRB-F(I)-20210097
- Conditions
- Head and Neck Cancer, Quality of Life, Pain, Sleep, Inhalation; Gas
- Keywords
- Head and Neck Cancer, Hydrogen, Cancer related symptom
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- OTA HYDROGEN SOLUTIONS LTD.
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen Inhalation | Experimental | Other: Hydrogen InhalationThe 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. |
| Ordinary Air Inhalation | Placebo comparator | Other: Ordinary Air InhalationThis group used the same model to inhale, but the gas released was only ordinary air, as a placebo control. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- With chronic obstructive pulmonary disease
- Having contraindications to use of low flow oxygen
- Feeling uncomfortable using nasal cannula for inhalation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen InhalationThe 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. | Other | Hydrogen Inhalation |
| Ordinary Air InhalationThe 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. | Other | Ordinary Air Inhalation |
Primary outcome
Change from Baseline MDASI-Taiwan Form at 3rd days, 7th days, 14th days
Time frame: Baseline, 3rd days, 7th days, 14th days
Using MDASI-Taiwan Form: Divided into two parts, the severity of symptom distress and the degree of interference with life, a total of 19 questions, each question is scored from 0 to 10, 0 is no trouble, 10 is the most serious, and the average score after the evaluation is ≥4 Points indicate significant symptom distress.
Change from Baseline VSH sleep scale at 3rd days, 7th days, 14th days
Time frame: Baseline, 3rd days, 7th days, 14th days
Using Verran and Snyder-Halpern Sleep Scale(VSH sleep scale): It is divided into three subscales of sleep disturbance, effective sleep and compensatory sleep, with a total of 15 items. Using the visual analog measurement method using a 10 cm horizontal line, patients are asked to self-evaluate their feelings about sleep the night before and then evaluate their sleep patterns. There are 8 forward questions and 7 reverse questions in the questions. The minimum score for each forward question is 0 and the highest is 100 points. The opposite is true for the reverse questions. The overall sleep quality score is the sum of the total scores of the three subscales. In total, the total score ranges from 0 to 1500, with lower scores indicating poorer sleep quality.
Change from Baseline BFI-Taiwan Form at 3rd days, 7th days, 14th days
Time frame: Baseline, 3rd days, 7th days, 14th days
Using Brief Fatigue Inventory-Taiwanese (BFI-Taiwan Form): It is divided into five major items and nine sub-questions, including: whether there is unusual fatigue or fatigue in a week, the current level of fatigue, the general level of fatigue in the past 24 hours, the most fatigued level in the past 24 hours, and the impact of fatigue on life in the past 24 hours Level of influence, including: general activities, mood, ability to walk, normal work, relationships with others, enjoyment of life, etc. Each question is scored from 0 to 10, with 0 being no distress and 10 being the most serious, and the average of the scores after evaluation is ≥ 4, indicating significant symptom distress.
Change from Baseline European Quality of Life Scal-Five Dimensions Questionnaire (EQ-5D or EuroQOL) at 3rd days, 7th days, 14th days
Time frame: Baseline, 3rd days, 7th days, 14th days
Using EQ-5D: It is composed of two parts. In the first part, the subjects need to answer the health status of the day, including five questions: action, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question has three options: "no problem", "some problem/moderate problem", "incapable of self-care/extreme problem", which can be weighted to get a single score. Five oriented questions can obtain 243 different health states, and through the group standard reference value established by time trade-off (TTO), a single EQ-5D score can be obtained after weighting (EQ-index ). The raw score on the EQ-5D was converted from -0.549 to 1, where 1 indicates "best state" quality of life, 0 indicates "death", and values below 0 indicate a state "worse than death".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YI-TSEN WU, Master principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen Inhalation and Ordinary Air Inhalation in people with Head and Neck Cancer and Quality of Life, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI-TSEN WU, Master (+886-910809542, yitsenwu1030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline MDASI-Taiwan Form at 3rd days, 7th days, 14th days (time frame: Baseline, 3rd days, 7th days, 14th days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.