Prospective Randomized Controlled Clinical Study for Lung Health Beverage in Preventing Radiotherapy-Related Lung Diseases in Locally Advanced Esophageal Cancer

Phase 2

Recruiting

• Conditions: esophageal cancer

• Registration Number: ITMCTR2000003345
• Lead Sponsor: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. pathological confirmed of esophageal squamous cell carcinoma;
2. TNM stage T3-4N0M0, TxN1-2M0, TxNxM1a (cervical lymph node metastasis);
3. Patients with expected survival >=6 months;
4. Patients aged 18 to 80 years;
5. Patients with ECOG 0-1;
6. Patients with sufficient main organ function
(1) Hemopoietic function: hemoglobin >= 100g/L, platelet >= 90 x 10^9/L, neutrophil >= 1.5x10^9/L;
(2) Renal function: serum creatinine SCR < 1.5 ULN;
(3) Liver function: ALT and AST < ULN one point five Times, bilirubin <1.5 x ULN;
7. The patient must sign the informed consent of receiving concurrent radiotherapy and chemotherapy.

Exclusion Criteria

1. Patients who have previously suffered from or complicated with other malignant tumors (except melanoma skin tumors) and whose diseases are not controlled or cured (depending on the disease type of the primary tumor);
2. Patients who have previously treated with thoracic radiotherapy;
3. Patients with congenital or acquired immune deficiency;
4. HIV positive patients, including those who have received antiretroviral therapy; chronic hepatitis B, virus replication period; active period of hepatitis C;
5. Pregnancy (confirmed by serum or urine beta- hCG test) or lactation period;
6. The general condition of the patients was poor, KPS < 70;
7. Patients have conditions that researchers believe may increase the risk of treatment or have serious uncontrollable complications.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acute radiation-induced lung disease;

Secondary Outcome Measures

Name	Time	Method
overall survival;late radiation-induced lung disease;overall survival;