NCT03581773

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Niels Fristrup · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Detailed description

Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI, immunotherapy or mTOR inhibitor treatment in mRCC patients. The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor treatment or immunotherapy and displaying CTCAE mucositis grade ≥2 can reduce the degree of mucositis, compared to PLACEBO. This is a randomized, double-blind, placebo-controlled phase II trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. Both arms will receive best supportive care. No crossover is allowed. The investigators anticipate a 96-month accrual period. The power calculation indicates a total of 50 patients per group are required. Block randomization based on received TKI/ mTOR inhibitor/IT-treatment will be performed.

Conditions

• Mucositis
• Stomatitis

Interventions

Type	Name	Description
DRUG	Folic Acid	5 mg pr day for 12 weeks
DRUG	Placebo Oral Tablet	1 placebo pill pr day for 12 weeks

Timeline

• Start date: 2017-12-20
• Primary completion: 2026-12-20
• Completion: 2028-12-20
• First posted: 2018-07-10
• Last updated: 2025-03-05

Locations

2 sites across 1 country: Denmark