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| Name | Class |
|---|---|
| Shanghai Asclepius Meditech Co., Ltd | UNKNOWN |
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The aim of this study is the efficacy of hydrogen gas immunotherapy to rehabilitation and prognosis of cancer patients.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxyhydrogen generator (AMS-H-03) | Experimental | 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). |
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| Control | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxyhydrogen generator (AMS-H-03) | Device | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival(PFS) | follow-up of CT scan | 1 year |
| Overall survival(OS) | follow-up survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Fuda cancer institute | Guangzhou | Guangdong | 510665 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33380580 | Derived | Chen JB, Kong XF, Qian W, Mu F, Lu TY, Lu YY, Xu KC. Two weeks of hydrogen inhalation can significantly reverse adaptive and innate immune system senescence patients with advanced non-small cell lung cancer: a self-controlled study. Med Gas Res. 2020 Oct-Dec;10(4):149-154. doi: 10.4103/2045-9912.304221. | |
| 32541132 | Derived |
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the patients will inhale hydrogen and oxygen with oxyhydrogen generator
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the experimental and control machines are of the same appearance and gas generation
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| analogue machine | Device | This machine has the same apperance and gas condition |
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| Chen JB, Kong XF, Mu F, Lu TY, Lu YY, Xu KC. Hydrogen therapy can be used to control tumor progression and alleviate the adverse events of medications in patients with advanced non-small cell lung cancer. Med Gas Res. 2020 Apr-Jun;10(2):75-80. doi: 10.4103/2045-9912.285560. |
| 31865734 | Derived | Chen J, Kong X, Mu F, Lu T, Du D, Xu K. Hydrogen-oxygen therapy can alleviate radiotherapy-induced hearing loss in patients with nasopharyngeal cancer. Ann Palliat Med. 2019 Nov;8(5):746-751. doi: 10.21037/apm.2019.11.18. |