Hydrogen Gas for Cancer Rehabilitation

Fuda Cancer Hospital, Guangzhou

Status: Completed

Conditions: Adult Solid Tumor

Treatments: Device: oxyhydrogen generator (AMS-H-03); Device: analogue machine

Study type: Interventional

Funder types: Other

Identifiers

NCT03818347

Hydrogen-cancer

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

oxyhydrogen generator (AMS-H-03)

Experimental group

Description:

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).

Treatment:

Device: oxyhydrogen generator (AMS-H-03)

Control

Placebo Comparator group

Description:

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).

Treatment:

Device: analogue machine