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This randomized study compared the incidence and severity of radiation esophagitis with folic acid and with conventional symptomatic treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Folic acid intervention |
|
| Routine | No Intervention | Routine treatment intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic acid | Drug | Folic acid was added during the period prior to concurrent chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of radiation esophagitis | A modified NCI-CTC score (the sum of dysphagia pain score and dysphagia pain score) was used to evaluate the occurrence of radioactive esophagitis. | day 1 up to 4 weeks after the end of treatment |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Lu, MD | Contact | 13809432527 | lbgymaaaa@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Lu, MD | The affiliated Cancer Hospital of Guizhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Cancer Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550025 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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. |
| day 1 up to 4 weeks after the end of treatment |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 | Heterocyclic Compounds |