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A clinical study on the efficacy of Xuefu Zhuyu Decoction in acute radiation esophagitis in esophageal cancer radiotherapy

Phase 1
Recruiting
Conditions
esophagus cancer
Registration Number
ITMCTR2100004685
Lead Sponsor
Affiliated Hospital of Nanjing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1.Patients with limited stage squamous cell carcinoma of the oesophagus with clear pathological diagnosis and suitable for concurrent radiotherapy;
2.KPS score >= 60 and expected survival > 3 months; can eat a liquid diet;
3.Tolerate and agree to receive concurrent radiotherapy;
4.Peripheral leukocytes >= 4.0 x 10^9/L, haemoglobin >= 90g/L and platelets >= 80 x 10^9/L before radiotherapy; no oesophageal perforation or active bleeding; no serious cardiac, pulmonary, hepatic or renal dysfunction or coagulation dysfunction;
5.No other contraindications to radiotherapy;
6.Willing to join this clinical study and sign the informed consent form.

Exclusion Criteria

1.Those with advanced disease who are not suitable for simultaneous radiotherapy;
2.Poor compliance; Allergy to experimental drugs;
3.Concurrent participation in other clinical trials;
4.Other serious illnesses, such as the combination of other tumours or serious infections;
5.Those with mental illness or mental retardation who are unable to express symptoms accurately.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Inflammatory factors;Indicators of radioactive esophagitis;Coagulation index;Radiosensitization index;
Secondary Outcome Measures
NameTimeMethod
Safety index;
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