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)
Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.
Signed written informed consent obtained prior to any study specific procedures.
Patient must be willing and able to comply with the protocol.
Age ≥ 18.
Known hypersensitivity to folic acid.
Use of prednisolone more than 10 mg daily.
Parallel
Folic Acid
Drug5 mg pr day for 12 weeks
Placebo Oral Tablet
Drug1 placebo pill pr day for 12 weeks
CTCAE Mucositis
The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).
PRO Mucositis frequency
The frequency of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.
Time to effect on mucositis
The median time to effect of study drug according to CTCAE 4.0 and PRO.
Dose reductions
The frequency of TKI/mTOR dose reductions in the two groups
Treatment discontinuations
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups
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Niels Fristrup
Lead sponsor
Aarhus University Hospital
Sponsor institution
