Hydrogen Gas for Cancer Rehabilitation

Not Applicable

Completed

• Conditions: Adult Solid Tumor
• Interventions: Device: oxyhydrogen generator (AMS-H-03); Device: analogue machine

• Registration Number: NCT03818347
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2018-06-02
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Status Verified: 2019-06
• Primary Completion: 2020-06-20
• Study Completion: 2020-08-20
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
oxyhydrogen generator (AMS-H-03)	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).
Control	analogue machine	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall survival（OS）	3 years	follow-up survival
Progress free survival（PFS）	1 year	follow-up of CT scan

Trial Locations

Locations (1)

Guangzhou Fuda cancer institute; 🇨🇳 Guangzhou, Guangdong, China