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Clinical Application and Mechanism Study of Moxibustion on Immune Function Regulation of Patients with Esophageal Carcinoma of Deficiency of Qi

Phase 1
Recruiting
Conditions
Esophageal cancer
Registration Number
ITMCTR2000003275
Lead Sponsor
Henan Province Hospital of TCM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

a. Age: 18 to 75 years old (>=18 years old, <=75 years old);
b. Stage III and IV esophageal squamous cell carcinoma confirmed by pathology;
c. TCM syndrome differentiation is the positive qi deficiency certificate;
d. Patients who meet the indications of chemotherapy and agree to receive chemotherapy treatment;
e. Physical condition score (KPS score) >= 60 points;
f. The expected survival time is >= 3 months, the main organs are in good function, and the blood routine test standards must be met (without blood transfusion and blood products within 14 days, without using G-CSF and other hematopoietic stimulating factors to correct): HB >= 90 g / L; WBC >= 3.5 x 10^9 / L; ANC >= 1.5 x 10^9 / L; PLT >= 80 x 10^9 / L. .
g. Patients with voluntary consent and good compliance with the informed consent;
h. Female subjects must take effective contraceptive measures throughout the study period; during screening and throughout the study period, serum or urine pregnancy test results must be negative; male subjects should be within the period of acceptance and within 1 month after completion of chemotherapy Take effective contraception.

Exclusion Criteria

a. Patients with diabetes, cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system or other serious diseases;
b. Patients with contagious infectious diseases;
c. There are contraindications for supervised moxibustion, such as joint deformities, unfavorable movement, disabled allergy for those who cannot prone for a long time, skin surface near the superficial veins that has not healed, or bleeding after injury is unknown;
d. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
KPS score;Bone marrow suppression;T lymphocyte subsets;Cancer patient quality of life assessment form;Serum immunoglobulin;
Secondary Outcome Measures
NameTimeMethod
PFS;Piper fatigue survey scale;TCM Syndrome Points Scale;
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