Folic Acid Supplement Compared to Placebo for Treating Mucositis in Patients with Metastatic Renal Cell Carcinoma Receiving Targeted Therapy A Randomized, Double-Blind Phase II Trial by the Danish Renal Cancer Group

What this Trial Is About

Researchers are evaluating whether taking folic acid supplements can help reduce mucositis, which includes inflammation and soreness in areas like the nose, mouth, throat, anus, or genital area, in patients with metastatic renal cell carcinoma mRCC who are receiving targeted treatments such as tyrosine kinase inhibitors TKI, immunotherapy, or mTOR inhibitors. This is a randomized, double-blind, placebo-controlled phase II study conducted by the Danish Renal Cancer Group to compare folic acid versus placebo for treating mucositis. Participants will be randomly assigned to one of two groups one group will receive a daily 5 mg folic acid tablet for 12 weeks, and the other will receive a placebo tablet daily for the same period. Both groups will continue to receive the best supportive care for their cancer and mucositis symptoms. No crossover between groups will be allowed during the study. The study plans to enroll about 100 patients over 96 months, with block randomization based on the type of cancer treatment patients are receiving. During the trial, participants will be monitored for mucositis severity using the Common Terminology Criteria for Adverse Events CTCAE over 16 weeks. Additional assessments include patient-reported mucositis frequency and severity, time to treatment effect, treatment dose reductions or discontinuations, gastrointestinal and skin-related side effects, and quality of life measures. Safety monitoring and adherence to the study drug will be conducted throughout the study duration.

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