Hydrogen Gas for Cancer Rehabilitation

Adult Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818347
• Other study ID #: Hydrogen-cancer
• Status: Completed
• Phase: N/A
• Start date: June 2, 2018
• Est. completion date: August 20, 2020

Study information

• Verified date: June 2019
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Solid Tumor

Intervention

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
• analogue machine
This machine has the same apperance and gas condition

Locations

Country	Name	City	State
China	Guangzhou Fuda cancer institute	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Shanghai Asclepius Meditech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

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