Hydrogen Gas for Cancer Rehabilitation

NCT ID: NCT03818347

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-02

Study Completion Date

2020-08-20

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).

Conditions

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Adult Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

the patients will inhale hydrogen and oxygen with oxyhydrogen generator
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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oxyhydrogen generator (AMS-H-03)

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).

Group Type EXPERIMENTAL

oxyhydrogen generator (AMS-H-03)

Intervention Type 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

Control

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).

Group Type PLACEBO_COMPARATOR

analogue machine

Intervention Type DEVICE

This machine has the same apperance and gas condition

Interventions

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oxyhydrogen 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

Intervention Type DEVICE

analogue machine

This machine has the same apperance and gas condition

Intervention Type DEVICE

Other Intervention Names

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hydrogen generator

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Asclepius Meditech Co., Ltd

UNKNOWN

Sponsor Role collaborator

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangzhou Fuda cancer institute

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33380580 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32541132 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31865734 (View on PubMed)

Other Identifiers

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Hydrogen-cancer

Identifier Type: -

Identifier Source: org_study_id

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