Folic Acid Interferes With Radiation Esophagitis

NCT05296369 | Unknown

• 1 other identifier: GZMU-FA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

  up to 12 months

Secondary Outcomes (2)

• Severity of radiation esophagitis

  day 1 up to 4 weeks after the end of treatment

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  day 1 up to 4 weeks after the end of treatment

Study Arms (2)

Experimental

EXPERIMENTAL

Folic acid intervention

Drug: Folic acid

Routine

NO INTERVENTION

Routine treatment intervention

Interventions

Folic acid DRUG

Folic acid was added during the period prior to concurrent chemoradiotherapy

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guizhou Medical University: lead

Study Sites (1)

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550025, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bing Lu, MD

  The affiliated Cancer Hospital of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Lu, MD

CONTACT

13809432527; lbgymaaaa@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 25, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

CN (1)