Status:

UNKNOWN

Folic Acid Interferes With Radiation Esophagitis

Lead Sponsor:

Guizhou Medical University

Conditions:

Lung Cancer

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

This randomized study compared the incidence and severity of radiation esophagitis with folic acid and with conventional symptomatic treatment.

Detailed Description

By prospective randomized controlled study, this study research plans to recruit with diagnosis of lung cancer patients, according to whether there is drug intervention were divided into treatment gro...

Eligibility Criteria

Inclusion

  • Patients with malignant lung cancer (incluedig Non-small cell lung cancer, small cell lung cancer) diagnosed by histopathology or cytology.
  • TNM Stage N2\~N3 (IASLC International TNM staging standard for Lung Cancer, 8th edition) was indicated by radiotherapy and the patients were treated for the first time.
  • Aged between 18 and 75 years old,no limit on the gender.
  • ECOG≤2 or KPS≥70.
  • No contraindication of Concurrent chemoradiotherapy.
  • Patients without important organ dysfunction,hematology: it is within the normal range according to the standards of each laboratory; Cardiac function: normal range; Liver function: normal range; Renal function: normal range; Pulmonary function: FEV1 \> 50%, mild to moderate impairment of pulmonary function.
  • Patients with good compliance to treatment received and follow-up.

Exclusion

  • Prior to treatment, there were other esophageal diseases, such as gastrointestinal ulcer, reflux esophagitis, cardia relaxation.
  • Patients with severe nutritional anemia prior to treatment.
  • The IV stage patients with uncontrolled malignant pleural effusion,with diffuse liver or lung metastasis which lead to liver or pulmonary dysfunction.
  • Patients with severe heart, lung or kidney diseass,such as uncontrolled hypertension, diabetes, unstable angina, a history of myocardial infarction or heart failure, or uncontrolled arrhythmias; There is clearly clinically diagnosed heart valve disease; The active phase of a bacterial, fungal, or viral infection; Mental disorders; Severely impaired lung function.
  • A history of previous tumors complicated with other malignant tumors.
  • The pregnant or breast-feeding patients.
  • Patients with mental and neurological diseases.

Key Trial Info

Start Date :

March 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2023

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT05296369

Start Date

March 1 2022

End Date

May 1 2023

Last Update

March 25 2022

Active Locations (1)

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1

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China, 550025