Folic Acid Interferes With Radiation Esophagitis

NCT ID: NCT05296369

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-05-31

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 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Folic acid intervention

Group Type: EXPERIMENTAL

Folic acid

Intervention Type: DRUG

Folic acid was added during the period prior to concurrent chemoradiotherapy

Routine

Routine treatment intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Folic acid

Folic acid was added during the period prior to concurrent chemoradiotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with malignant lung cancer (incluedig Non-small cell lung cancer, small cell lung cancer) diagnosed by histopathology or cytology.

2. 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.

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 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.

7. Patients with good compliance to treatment received and follow-up.

Exclusion Criteria

1. Prior to treatment, there were other esophageal diseases, such as gastrointestinal ulcer, 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 liver or 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, 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guizhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bing Lu, MD

Role: PRINCIPAL_INVESTIGATOR

The affiliated Cancer Hospital of Guizhou Medical University

Locations

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bing Lu, MD

Role: CONTACT

lbgymaaaa@sohu.com

13809432527

Facility Contacts

Hao Zhang

Role: primary

86-18586915695

Other Identifiers

GZMU-FA

Identifier Type: -

Identifier Source: org_study_id