NCT03818347

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

October 19, 2020

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

January 22, 2019

Last Update Submit

October 13, 2020

Conditions

Adult Solid Tumor

Keywords

Solid tumorHydrogen gas

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Progress free survival（PFS）

    1 year

  • Overall survival（OS）

    3 years

Study Arms (2)

oxyhydrogen generator (AMS-H-03)

EXPERIMENTAL

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)

Control

PLACEBO COMPARATOR

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

Interventions

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

Also known as: hydrogen generator
oxyhydrogen generator (AMS-H-03)
analogue machineDEVICE

This machine has the same apperance and gas condition

Control

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Fuda cancer institute

Guangzhou, Guangdong, 510665, China

Location

Related Publications (3)

  • Chen JB, Kong XF, Qian W, Mu F, Lu TY, Lu YY, Xu KC. Two weeks of hydrogen inhalation can significantly reverse adaptive and innate immune system senescence patients with advanced non-small cell lung cancer: a self-controlled study. Med Gas Res. 2020 Oct-Dec;10(4):149-154. doi: 10.4103/2045-9912.304221.

    PMID: 33380580DERIVED

  • Chen JB, Kong XF, Mu F, Lu TY, Lu YY, Xu KC. Hydrogen therapy can be used to control tumor progression and alleviate the adverse events of medications in patients with advanced non-small cell lung cancer. Med Gas Res. 2020 Apr-Jun;10(2):75-80. doi: 10.4103/2045-9912.285560.

    PMID: 32541132DERIVED

  • Chen J, Kong X, Mu F, Lu T, Du D, Xu K. Hydrogen-oxygen therapy can alleviate radiotherapy-induced hearing loss in patients with nasopharyngeal cancer. Ann Palliat Med. 2019 Nov;8(5):746-751. doi: 10.21037/apm.2019.11.18.

    PMID: 31865734DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
the experimental and control machines are of the same appearance and gas generation
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: the patients will inhale hydrogen and oxygen with oxyhydrogen generator
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 28, 2019

Study Start

June 2, 2018

Primary Completion

June 20, 2020

Study Completion

August 20, 2020

Last Updated

October 19, 2020

Record last verified: 2019-06

Locations

CN(1)