Folic Acid Interferes With Radiation Esophagitis

March 24, 2022 updated by: Guizhou Medical University

Randomized Controlled Clinical Study of Folic Acid Treatment of Radiation Esophagitis After Chemoradiation in Lung Cancer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550025
        • Recruiting
        • The Affiliated Cancer Hospital of Guizhou Medical University
        • Contact:
          • Hao Zhang
          • Phone Number: 86-18586915695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Folic acid intervention
Drug: Folic acid
Folic acid was added during the period prior to concurrent chemoradiotherapy
No Intervention: Routine
Routine treatment intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival(PFS)
Time Frame: 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.
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of radiation esophagitis
Time Frame: 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.
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
Time Frame: 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.
day 1 up to 4 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guizhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bing Lu, MD, The Affiliated Cancer Hospital of Guizhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GZMU-FA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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