NCT03581773 Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy
| NCT ID | NCT03581773 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Niels Fristrup |
| Condition | Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-12-20 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2017-12-20 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03581773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03581773 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03581773 currently recruiting?
Yes, NCT03581773 is actively recruiting participants. Contact the research team at niels.fristrup@rm.dk for enrollment information.
Where is the NCT03581773 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herlev, Denmark.
Who is sponsoring the NCT03581773 clinical trial?
NCT03581773 is sponsored by Niels Fristrup. The trial plans to enroll 100 participants.