Hydrogen Gas for Cancer Rehabilitation

• ClinicalTrials.gov Identifier: NCT03818347
• Recruitment Status: Completed
• First Posted: January 28, 2019
• Last Update Posted: October 19, 2020
• Sponsor: Fuda Cancer Hospital, Guangzhou
• Collaborator: Shanghai Asclepius Meditech Co., Ltd
• Information provided by (Responsible Party): Fuda Cancer Hospital, Guangzhou

Tracking Information

• First Submitted Date: January 22, 2019
• First Posted Date: January 28, 2019
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: June 2, 2018
• Actual Primary Completion Date: June 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2019)

• 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
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 24, 2019)

• Progress free survival（PFS） [ Time Frame: 1 year ]
  follow-up of CT scan
• Overall survival（OS） [ Time Frame: 3 years ]
  follow-up survival

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hydrogen Gas for Cancer Rehabilitation
• Official Title: Hydrogen Gas Immunotherapy Promotes the Rehabilitation and Prognosis of Cancer Patients After Standard Treatments
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

the patients will inhale hydrogen and oxygen with oxyhydrogen generator

Masking: Single (Investigator)
Masking Description:

the experimental and control machines are of the same appearance and gas generation

Primary Purpose: Treatment

• Condition: 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
  Other Name: hydrogen generator
• Device: analogue machine
  This machine has the same apperance and gas condition

Study Arms

• Experimental: 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).
  Intervention: Device: oxyhydrogen generator (AMS-H-03)
• Placebo Comparator: Control
  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).
  Intervention: Device: analogue machine

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 13, 2020): 30
• Original Estimated Enrollment (submitted: January 24, 2019): 200
• Actual Study Completion Date: August 20, 2020
• Actual Primary Completion Date: June 20, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03818347
• Other Study ID Numbers: Hydrogen-cancer
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fuda Cancer Hospital, Guangzhou
• Original Responsible Party: Same as current
• Current Study Sponsor: Fuda Cancer Hospital, Guangzhou
• Original Study Sponsor: Same as current
• Collaborators: Shanghai Asclepius Meditech Co., Ltd
• Investigators: Not Provided
• PRS Account: Fuda Cancer Hospital, Guangzhou
• Verification Date: June 2019