Hydrogen Gas for Cancer Rehabilitation

Conditions

Adult Solid Tumor

Keywords

Solid tumor, Hydrogen gas

Brief summary

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

Detailed description

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).

Kecheng Xu, Jibing Chen, Xiaofeng Kong, Feng Mu, Tianyu Lu et al. (6 authors)

Medical Gas Research2020-01-0137 citations

10.4103/2045-9912.285560

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

Kecheng Xu, Jibing Chen, Xiaofeng Kong, Wei Qian, Feng Mu et al. (7 authors)

Medical Gas Research2020-01-0133 citations

10.4103/2045-9912.304221

Hydrogen–oxygen therapy can alleviate radiotherapy-induced hearing loss in patients with nasopharyngeal cancer

Jibing Chen, Xiaofeng Kong, Feng Mu, Tianyu Lu, Duanming Du et al. (6 authors)

Annals of Palliative Medicine2019-11-0112 citations

10.21037/apm.2019.11.18

Interventions

DEVICEoxyhydrogen generator (AMS-H-03)

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

DEVICEanalogue machine

This machine has the same apperance and gas condition

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

the experimental and control machines are of the same appearance and gas generation

Intervention model description

the patients will inhale hydrogen and oxygen with oxyhydrogen generator

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement of sleep, diet and exercise	3 months	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
Improvement of immune function	3 months	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.

Secondary

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

Countries

China

Outcome results

None listed