Clinical trial NCT05728112: Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients
Official title: Effectiveness Verification of Using Hydrogen Inhalation to Improve Fatigue, Pain and Quality of Life in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Quality of Life
Pain
Sleep
Inhalation; Gas
Keywords: Head and Neck Cancer
Hydrogen
Cancer related symptom
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: OTA HYDROGEN SOLUTIONS LTD.
First posted: 2023-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change from Baseline MDASI-Taiwan Form at 3rd days, 7th days, 14th days
timeFrame: Baseline, 3rd days, 7th days, 14th days
measure: Change from Baseline VSH sleep scale at 3rd days, 7th days, 14th days
timeFrame: Baseline, 3rd days, 7th days, 14th days
measure: Change from Baseline BFI-Taiwan Form at 3rd days, 7th days, 14th days
timeFrame: Baseline, 3rd days, 7th days, 14th days
measure: Change from Baseline European Quality of Life Scal-Five Dimensions Questionnaire (EQ-5D or EuroQOL) at 3rd days, 7th days, 14th days
timeFrame: Baseline, 3rd days, 7th days, 14th days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: YI-TSEN WU, Master
role: PRINCIPAL_INVESTIGATOR
References: