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Hydrogen Gas for Cancer Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03818347
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Shanghai Asclepius Meditech Co., Ltd
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
Adult Solid Tumor Device: oxyhydrogen generator (AMS-H-03) Device: analogue machine Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: the patients will inhale hydrogen and oxygen with oxyhydrogen generator
Masking: Single (Investigator)
Masking Description: the experimental and control machines are of the same appearance and gas generation
Primary Purpose: Treatment
Official Title: Hydrogen Gas Immunotherapy Promotes the Rehabilitation and Prognosis of Cancer Patients After Standard Treatments
Actual Study Start Date : June 2, 2018
Actual Primary Completion Date : June 20, 2020
Actual Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: 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).
Device: 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
Other Name: hydrogen generator

Placebo Comparator: 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).
Device: analogue machine
This machine has the same apperance and gas condition




Primary Outcome Measures :
  1. Improvement of sleep, diet and exercise [ Time Frame: 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

  2. Improvement of immune function [ Time Frame: 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 Outcome Measures :
  1. Progress free survival(PFS) [ Time Frame: 1 year ]
    follow-up of CT scan

  2. Overall survival(OS) [ Time Frame: 3 years ]
    follow-up survival



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818347


Locations
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China, Guangdong
Guangzhou Fuda cancer institute
Guangzhou, Guangdong, China, 510665
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shanghai Asclepius Meditech Co., Ltd
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03818347    
Other Study ID Numbers: Hydrogen-cancer
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Solid tumor
Hydrogen gas