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Folic Acid Interferes With Radiation Esophagitis

China90 participantsStarted 2022-03-01

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Progression-free survival(PFS)

Timeframe: up to 12 months

NCT IDNCT05296369

SponsorGuizhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05

Bing Lu, MD

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.