NCT03581773CompletedPhase 2
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)
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 7 May 2018
- Start date
- 20 Dec 2017
- Primary completion date
- 22 Sept 2026
- Lead sponsor
- Niels Fristrup
- Diseases
- Kidney cancer
- NCT number
- NCT03581773
- EU CT number
- 2024-515413-18-00
- EudraCT number
- 2016-001193-15
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 84
- From 20 Dec 2017 to the primary completion date, 22 Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to folic acid.
Other
- Use of prednisolone more than 10 mg daily.
Who the study is looking for
- 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%.
Criteria the registry did not label
- Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.