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A study to examine the safety and effects of preoperative home-based hydrogen gas inhalation therapy for liver cancer patients

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	primary or metastatic liver cancer
Date of first enrollment	26/01/2026
Target sample size	8
Countries of recruitment
Study type	Interventional
Intervention(s)	Hydrogen gas inhalation therapy will be administered at home to patients awaiting liver resection for liver cancer, using a nasal cannula. The therapy will be performed for approximately 6 hours during sleep and 1 hour each in the morning and evening, every day for 14 consecutive days.

Outcome(s)

Primary Outcome

Treatment adherence rate of home-based hydrogen gas inhalation therapy

Secondary Outcome

1. Duration of hydrogen gas generation 2. Changes in inflammation and immune-related indices (CRP, LMR, NLR, PI, PLR, SIII, SIRI) 3. Changes in nutrition and inflammation indices (GPS, CAR, PNI, CONUT) 4. Changes in body composition (total body water, muscle mass [trunk and limbs], body fat mass) 5. Impact on physical and psychological symptoms (assessed using the EORTC QLQ-C30) 6. Changes in oxidative stress markers (urinary 8-OHdG) 7. Changes in tumor markers (AFP, AFP-L3, PIVKA-2, CEA, CA19-9) 8. Adverse events

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 80age old
Gender	Both
Include criteria	1. Patients aged 18 years or older and 80 years or younger at the time of obtaining informed consent (regardless of sex). 2. Patients who are scheduled to undergo surgery for primary or metastatic liver cancer at the time of enrollment. 3. Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1. 4. Patients who meet all of the following laboratory criteria on the date of registration: A) White blood cell count: greater than or equal to 2,000 /mm3 B) Hemoglobin: greater than or equal to 7.0 g/dL C) Platelet count: greater than or equal to 30,000 /mm3 D) Total bilirubin: less than 5.0 mg/dL E) Serum creatinine: less than 2.0 mg/dL 5. Patients with sufficient cognitive ability to understand the study and who can provide written informed consent for participation.
Exclude criteria	1. Patients who are already receiving hydrogen therapy on a regular basis. 2. Patients who are deemed unable to perform home-based hydrogen gas inhalation, due to conditions such as nasal obstruction, skin hypersensitivity, or inability to operate the device. 3. Patients with severe respiratory disorders (e.g., Hugh-Jones classification grade IV or higher) or those requiring continuous oxygen therapy due to interstitial pneumonia, pulmonary fibrosis, or other respiratory conditions. 4. Patients with psychiatric disorders or symptoms that may interfere with study participation. 5. Patients who are considered inappropriate for study participation by the principal investigator or sub-investigators.