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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Mucositis, Stomatitis

In brief

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)

Key facts

Study ID: NCT03581773
Run by: Niels Fristrup
People needed: 100
Starts: 2017-12-20
Expected to finish: 2029-09-01
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.
Biopsy proven locally advanced or metastatic renal cell carcinoma.
Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
Karnofsky Performance status ≥ 60%.

You may not qualify if…

Known hypersensitivity to folic acid.
Use of prednisolone more than 10 mg daily.

Where it is running

Aarhus University Hospital, Department of oncology — Aarhus, Central Region of Denmark, Denmark (enrolling)
Department of Oncology, Herlev Hospital — Herlev, Denmark (enrolling)

Full record on ClinicalTrials.gov

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