Clinical trial NCT05296369: Folic Acid Interferes With Radiation Esophagitis
Official title: Randomized Controlled Clinical Study of Folic Acid Treatment of Radiation Esophagitis After Chemoradiation in Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Guizhou Medical University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: up to 12 months
Secondary outcomes:
measure: Severity of radiation esophagitis
timeFrame: day 1 up to 4 weeks after the end of treatment
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: day 1 up to 4 weeks after the end of treatment
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The Affiliated Cancer Hospital of Guizhou Medical University
state: Guizhou
Study officials:
affiliation: The affiliated Cancer Hospital of Guizhou Medical University
name: Bing Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: