Folic Acid Interferes With Radiation Esophagitis

Last updated: March 24, 2022
Sponsor: Guizhou Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Esophageal Disorders

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT05296369
GZMU-FA
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Prior to treatment, there were other esophageal diseases, such as gastrointestinalulcer, reflux esophagitis, cardia relaxation.
  2. Patients with severe nutritional anemia prior to treatment.
  3. The IV stage patients with uncontrolled malignant pleural effusion,with diffuse liveror lung metastasis which lead to liver or pulmonary dysfunction.
  4. Patients with severe heart, lung or kidney diseass,such as uncontrolled hypertension,diabetes, unstable angina, a history of myocardial infarction or heart failure, oruncontrolled 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.
  5. A history of previous tumors complicated with other malignant tumors.
  6. The pregnant or breast-feeding patients.
  7. Patients with mental and neurological diseases.

Study Design

Total Participants: 90
Study Start date:
March 01, 2022
Estimated Completion Date:
May 31, 2023

Study 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 group and control group, compared two groups of acute radiation esophagitis in the before and after the intervention, extent of occurrence of folic acid and clinical curative effect, so as to verify whether folic acid can be used as an intervention in the treatment of radioactive esophagitis, To explore the safety of folic acid in the treatment of radioactive esophagitis and explore the standardized treatment of radioactive esophagitis.

Connect with a study center

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou 550025
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.