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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNiels Fristrup

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Known hypersensitivity to folic acid.

Use of prednisolone more than 10 mg daily.

Trial design

Treatments tested in this trial

  • Folic Acid
  • Placebo Oral Tablet

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Niels Fristrup

Lead sponsor

Aarhus University Hospital

Sponsor institution