Pain Clinical Trial
— hydrogenOfficial title:
Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Medical University Chung-Ho Memorial Hospital | OTA HYDROGEN SOLUTIONS LTD. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 3rd days, 7th days, 14th days | |
Primary | 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. | Baseline, 3rd days, 7th days, 14th days | |
Primary | 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. | Baseline, 3rd days, 7th days, 14th days | |
Primary | 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". | Baseline, 3rd days, 7th days, 14th days |
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