Lung CancerNCT05296369
Folic Acid Interferes With Radiation Esophagitis
A study testing Folic acid in people with Lung Cancer, run by Guizhou Medical University at 1 site in China.
Trial summary
This randomized study compared the incidence and severity of radiation esophagitis with folic acid and with conventional symptomatic treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550025
Hao Zhang, 86-18586915695
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Folic acid
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDrug
Folic acid was added during the period prior to concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Folic acid intervention Receives: Drug: Folic acid |
| Routine | No intervention | Routine treatment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: day 1 up to 4 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Mar 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bing Lu, MD, Principal investigator, The affiliated Cancer Hospital of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296369
- Sponsor's protocol ID
- GZMU-FA
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study of Folic Acid Treatment of Radiation Esophagitis After Chemoradiation in Lung Cancer
- ClinicalTrials.gov ID
- NCT05296369
- Acronym / sponsor ID
- GZMU-FA
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Folic acidFolic acid intervention |
| Routine | No intervention | –Routine treatment intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acidFolic acid was added during the period prior to concurrent chemoradiotherapy | Drug | Experimental |
Primary outcome
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.
2 secondary outcomes
Severity of radiation esophagitis
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing Lu, MD principal investigator
The affiliated Cancer Hospital of Guizhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid in people with Lung Cancer, run by Guizhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Lu, MD (13809432527, lbgymaaaa@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.