RecruitingPhase 2NCT03581773

Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy

FASTERCC: Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy. A Randomized, Double-blind Trial From the Danish Renal Cancer Group (DARENCA Study-4)


Sponsor

Niels Fristrup

Enrollment

100 participants

Start Date

Dec 20, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether taking folic acid (a B vitamin supplement) can reduce painful mouth sores (mucositis) — a common and uncomfortable side effect — in patients with advanced kidney cancer who are receiving targeted therapy drugs. **You may be eligible if...** - You have inoperable, locally advanced, or metastatic (spread) kidney cancer confirmed by biopsy - You are currently receiving targeted therapy (such as TKI, mTOR inhibitor, or immunotherapy) and experiencing moderate to severe mouth sores (grade 2 or higher on the CTCAE scale) - You are 18 years of age or older - You are willing to follow the study protocol **You may NOT be eligible if...** - You are pregnant (unless pregnancy can be excluded by other means, such as menopause or prior surgery) - You are not currently experiencing mouth sores from your treatment - You are unwilling or unable to comply with study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFolic Acid

5 mg pr day for 12 weeks

DRUGPlacebo Oral Tablet

1 placebo pill pr day for 12 weeks


Locations(2)

Aarhus University Hospital, Department of oncology

Aarhus, Central Region of Denmark, Denmark

Department of Oncology, Herlev Hospital

Herlev, Denmark

View Full Details on ClinicalTrials.gov

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NCT03581773


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