Clinical trial · Interventional
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)
NCT03581773CI-TRIAL-00110269DARENCA4completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folic Acid | Drug | — | UNRESOLVED |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment arm
- description
- 5 mg of folic acid (1 tablet) per day for 12 weeks.
- interventionNames
- Drug: Folic Acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- PLACEBO (1 tablet) per day for 12 weeks.
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- CTCAE Mucositis
- timeFrame
- 16 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma. Inclusion Criteria: 1. Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment. 2. Signed written informed consent obtained prior to any study specific procedures. 3. Patient must be willing and able to comply with the protocol. 4. Age ≥ 18. 5. Biopsy proven locally advanced or metastatic renal cell carcinoma. 6. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating. 7. 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). 8. Karnofsky Performance status ≥ 60%. Exclusion Criteria: 1. Known hypersensitivity to folic acid. 2. Use of prednisolone more than 10 mg daily.
References
Publications (1)
- DERIVEDFristrup N, Donskov F. Folic Acid Reduces Mucositis in Metastatic Renal Cell Carcinoma Patients: A Retrospective Study. Clin Genitourin Cancer. 2019 Aug;17(4):254-259. doi: 10.1016/j.clgc.2019.03.023. Epub 2019 Apr 6. PMID 31101577