Folic Acid Interferes With Radiation Esophagitis

Not Applicable

• Conditions: Lung Cancer
• Interventions: Drug: Folic acid

• Registration Number: NCT05296369
• Lead Sponsor: Guizhou Medical University

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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-24
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-03-25
• Last Update Posted: 2022-03-25
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Folic acid	Folic acid intervention

Primary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	up to 12 months	PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
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	To assess and record nausea, vomiting, hematologic toxicity,radiation pneumonitis and other treantment complications by CTCAE v5.0.Hematotoxicity includes white blood cell count (The normal range count is 3.5 to 9.5×10\^9/L), neutrophil count(The normal range count is 1.8 to 6.3×10\^9/L), platelet count(The normal range count is 125 to 350×10\^9/L), hemoglobin count(The normal range count is 115 to 175g/L),measuring creatinine value（The normal value of creatinine is 44to106μmol/L）, endogenous creatinine clearanceThe normal value of creatinine is 80 to120 mo/min）, bilirubin（Including total bilirubin, direct bilirubin and indirect bilirubin,), aspartate aminotransferase(AST, The normal value of AST is 13 to 40u/L)and alanine aminotransferase(ALT, The normal value of ALT is 7 to 50u/L).The severity of radiational pneumonitis can be evaluated by the Radiation Therapy Oncology Group（RTOG）morbidity grading criteria.
Severity of radiation esophagitis	day 1 up to 4 weeks after the end of treatment	A modified NCI-CTC score (the sum of dysphagia pain score and dysphagia pain score) was used to evaluate the occurrence of radioactive esophagitis.

Trial Locations

Locations (1)

The Affiliated Cancer Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China