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Completed

NCT Number: NCT03818347

Hydrogen Gas for Cancer Rehabilitation

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

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Key information

Conditions

Adult Solid Tumor

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Fuda cancer institute

Guangzhou, Guangdong, 510665, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxyhydrogen generator (AMS-H-03)

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

Other names: hydrogen generator

analogue machine

Device

This machine has the same apperance and gas condition

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Shanghai Asclepius Meditech Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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