Hydrogen Gas for Cancer Rehabilitation

Study Overview
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Brief Summary
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The aim of this study is the efficacy of hydrogen gas immunotherapy to rehabilitation and prognosis of cancer patients.

Detailed Description
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By enrolling patients of multiple kinds of cancer adapted to enrolled criteria, this study will document for the first time the short and long term efficacy of hydrogen gas.The evaluation indexes include peripheral blood lymphocyte immunoassay, improvement of sleep, diet and exercise, progress free survival (PFS) and overall survival (OS).

Official Title
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Hydrogen Gas Immunotherapy Promotes the Rehabilitation and Prognosis of Cancer Patients After Standard Treatments

Conditions
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Adult Solid Tumor

Intervention / Treatment
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* Device: oxyhydrogen generator (AMS-H-03)
* Device: analogue machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Standard therapies have finished according to NCCN guidelines or the patient refuses standard therapies Body tumor 1-6, the maximum tumor length < 2 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: the patients will inhale hydrogen and oxygen with oxyhydrogen generator
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxyhydrogen generator (AMS-H-03)<br>Model: AMS-H-03 Rated gas output (L) : 3L/min, concentration of hydrogen and the oxygen was 66.6% and 33.3%, respectively In this group, the patients will inhale hydrogen and oxygen with oxyhydrogen generator. The check indexes are questionnaire of sleep, diet and exercise, CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Device: oxyhydrogen generator (AMS-H-03)<br>* Rated gas output (L) : 3L/min, concentration of hydrogen and the oxygen was 66.6% and 33.3%, respectively. The patients inhale 3 hours each day through a cannula or mask, and persist for long term<br>* Other names: hydrogen generator;|
| Placebo Comparator: Control<br>In this group, the patients will inhale normal air with analogue machine. The check indexes are questionnaire of sleep, diet and exercise, CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Device: analogue machine<br>* This machine has the same apperance and gas condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of sleep, diet and exercise | It will be evaluated by the questionnaire of EORTC QLQ-C30. The scores of each index before and after treatment need to be analyzed by statistical methods to reach a conclusion, and P< 0.05 is considered to be statistically different | 3 months | 
| Improvement of immune function | It will be evaluated by the blood test, including tumor marker alpha fetoprotein (AFP), lymphocyte subsets (T and NK cells) and circulating tumor cell (CTCs). The reference range of AFP is 0-40 IU/mL, higher than this range indicates tumor risk, and the higher the value is, the faster the tumor growth rate will be. The t-cell range of the lymphocyte subclass is 603-2990 cell/uL, and the NK cell range is 95-640 cell/uL, lower than the reference range indicates low immune function. The CTC reference range is 0-1, and higher than the reference range indicates tumor activity. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival（PFS） | follow-up of CT scan | 1 year | 
| Overall survival（OS） | follow-up survival | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumor, Hydrogen gas