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Folic Acid Interferes With Radiation Esophagitis

Primary Purpose

Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Folic acid

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

The Affiliated Cancer Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Routine

Arm Description

Folic acid intervention

Routine treatment intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

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.

Full Information

NCT ID

NCT05296369

First Posted

March 4, 2022

Last Updated

March 24, 2022

Sponsor

Guizhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05296369

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guizhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Folic acid intervention

Arm Title

Routine

Arm Type

No Intervention

Arm Description

Routine treatment intervention

Intervention Type

Drug

Intervention Name(s)

Folic acid

Intervention Description

Folic acid was added during the period prior to concurrent chemoradiotherapy

Primary Outcome Measure Information:

Title

Progression-free survival(PFS)

Description

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Severity of radiation esophagitis

Description

A modified NCI-CTC score (the sum of dysphagia pain score and dysphagia pain score) was used to evaluate the occurrence of radioactive esophagitis.

Time Frame

day 1 up to 4 weeks after the end of treatment

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Description

Time Frame

day 1 up to 4 weeks after the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bing Lu, MD

Phone

13809432527

lbgymaaaa@sohu.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bing Lu, MD

Organizational Affiliation

The affiliated Cancer Hospital of Guizhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Affiliated Cancer Hospital of Guizhou Medical University

City

Guiyang

State/Province

Guizhou

ZIP/Postal Code

550025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hao Zhang

Phone

86-18586915695

12. IPD Sharing Statement

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Folic Acid Interferes With Radiation Esophagitis

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