Hydrogen Gas Immunotherapy Promotes the Rehabilitation and Prognosis of Cancer Patients After Standard Treatments
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adult Solid Tumor
- Sponsor
- Fuda Cancer Hospital, Guangzhou
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement of sleep, diet and exercise
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall survival（OS）(3 years)
- Progress free survival（PFS）(1 year)