Clinical trial · Interventional
Folic Acid Interferes With Radiation Esophagitis
Randomized Controlled Clinical Study of Folic Acid Treatment of Radiation Esophagitis After Chemoradiation in Lung Cancer
NCT05296369CI-TRIAL-00057335unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized study compared the incidence and severity of radiation esophagitis with folic acid and with conventional symptomatic treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Folic acid intervention
- interventionNames
- Drug: Folic acid
- type
- NO_INTERVENTION
- label
- Routine
- description
- Routine treatment intervention
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- up to 12 months
- description
- PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.