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A Multicenter Randomized Controlled Clinical Trial on the Efficacy of Jishi Shuanghua Formula in the Treatment of Acute Radiation Esophagitis

A Multicenter Randomized Controlled Clinical Trial on the Efficacy of Jishi Shuanghua Formula in the Treatment of Acute Radiation Esophagitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000641
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Radiation-Induced Esophagitis

Interventions

Experimental Group:Jishi Shuanghua Granule

Sponsors

Leshan City Shizhong District Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age between 18 and 75 years; 2) Pathologically confirmed non-small cell lung cancer, staged as III (according to the 8th edition of the American Joint Committee on Cancer standards); 3) Clinically assessed as unresectable and planned to undergo definitive concurrent chemoradiotherapy (CCRT); 4) Mean esophageal dose > 20 Gy; 5) Normal hematological, hepatic, and renal function; 6) Karnofsky Performance Status (KPS) score = 70.

Exclusion criteria

Exclusion criteria: 1) Previous history of thoracic radiotherapy; 2) Women who are pregnant or breastfeeding; 3) Inability to take oral medication adequately; 4) History of esophageal diseases, including but not limited to esophageal cancer, active reflux esophagitis, and esophageal reconstruction.

Design outcomes

Primary

MeasureTime frame
Grading of Acute Radiation Esophagitis;

Secondary

MeasureTime frame
Acute Radiation Esophagitis-Related Pain Score;Short-term Efficacy of Lung Cancer Treatment (Disease Control Rate and Objective Response Rate);Quality of Life Score;Acute Radiation Esophagitis-Related Dysphagia Score;Long-term Efficacy of Lung Cancer Treatment (Progression-Free Survival and Overall Survival );

Countries

China

Contacts

Public ContactYuanyuan Zheng

Leshan City Shizhong District Cancer Hospital

2464346396@qq.com17502870915

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 25, 2026