Lung Cancer
Conditions
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.
Interventions
DRUGFolic acid
Folic acid was added during the period prior to concurrent chemoradiotherapy
Sponsors
Guizhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactBing Lu, MD
Outcome results
None listed