Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Respiratory Aspiration

Fatigue

Pain

Head and Neck Neoplasms

Respiration Disorders

Respiratory Tract Diseases

Quality of Life

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.

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

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.

Hydrogen 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.

Ordinary Air Inhalation

YI-TSEN WU, Master

Pi-Ling Chou, PHD

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.

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.

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

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.

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.

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.

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".

OTA HYDROGEN SOLUTIONS LTD.

Kaohsiung Medical University Chung-Ho Memorial Hospital

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antioxidants

Five times per day for 6 weeks subjects will dissolve a hydrogen generating tablet into water and drink the effervescent water. Dissolving one tablet in 250 mL of water will achieve a saturating hydrogen concentration of approximately 1.6 ppm.

Five times per day for 6 weeks subjects will dissolve an placebo tablet into water and drink the effervescent water. The effervescent placebo tablet does not generate hydrogen-enriched water.

Each hydrogen tablet contains 80 mg magnesium

Hydrogen

Matching placebo tablet also contains 80 mg magnesium

Placebo oral tablet

Agnieszka Kowalska, MD

This is a pilot randomized control trial (RCT) to explore the effects of hydrogen rich water on quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide.

This will be a pilot trial exploring the ability of molecular hydrogen to improve quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide. Hydrogen has an excellent safety profile, has antioxidant properties and reduces inflammatory events in the tissues. It has been postulated in previous studies that continuous consumption of hydrogen water reduces oxidative stress in the brain by lowering the concentration of the reactive oxygen species, resulting in the improvement of adult neurogenesis or the stimulation of neural proliferation, leading to the prevention of the decline in the learning and memory.

This will be a double blinded, placebo-controlled trial. Eligible and willing subjects will be randomly assigned in a 2:1 ratio to be treated with either hydrogen or placebo, to receive hydrogen or placebo, additionally to all standard-of-care treatments. The treatment with hydrogen or placebo will start the day before chemoradiation therapy starts, and continue for six weeks. The effects of drinking hydrogen water on the quality of life will be assessed using the EORTC QLQ-C30 and the EORTC QLQ-BN20 questionnaires at baseline, at 6 weeks, 6 months, 12 months, 18 months and 24 months.

The subjects will be randomly assigned in a 2:1 ratio to receive hydrogen or placebo, additionally to all standard-of-care treatments by the SB Research Pharmacy. Masking of active and placebo treatments will be preserved by creating study medication containers that appear identical.

Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.

Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.

Feasibility of recruitment, assessment procedures, treatment, and outcome measures will be evaluated. Number of screened / eligible / enrolled patients, treatment adherence, assessment completion, subject dropout, data completeness, and data variability.

Change in health related quality of life from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the EORTC QLQ-C30 score. The score range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Change in health related quality of life from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the EORTC QLQ-BN20 score. The score range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Change in memory from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the Mini-Mental State Examination (MMSE).

Change in Karnofsky performance score (KPS) from baseline to week 6, month 6, month 12, month 18, and month 24.

Overall survival is defined as the time from randomization until death from any cause. PFS is defined as the time from randomization until tumor progression (defined by McDonald's criteria).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients	NCT05728112	Head and Neck C... Quality of Life Pain Sleep Inhalation; Gas	Hydrogen Inhala... Ordinary Air In...	20 Years - 90 Years	Kaohsiung Medical University Chung-Ho Memorial Hospital
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.	NCT04175301	Malignant Gliom...	Hydrogen Placebo oral ta...	18 Years -	Stony Brook University
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.	NCT04175301	Malignant Gliom...	Hydrogen Placebo oral ta...	18 Years -	Stony Brook University
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.	NCT04175301	Malignant Gliom...	Hydrogen Placebo oral ta...	18 Years -	Stony Brook University

Spots Global Cancer Trial Database for hydrogen

Every month we try and update this database with for hydrogen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hydrogen

Every month we try and update this database with for hydrogen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hydrogen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.