RecruitingPhase 2

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

Denmark100 participantsStarted 2017-12-20

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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%.

Exclusion criteria

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

What they're measuring

CTCAE Mucositis

Timeframe: 16 weeks

Trial details

NCT IDNCT03581773

SponsorNiels Fristrup

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Niels Fristrup, MD PhD

004520914161 niels.fristrup@rm.dk

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