← Back to all trials
Completed
NCT03581773
Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy
Conditions: Mucositis, Stomatitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 84
Sponsor: Niels Fristrup
Location: Aarhus University Hospital, Department of oncology Aarhus Central Region of Denmark
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 (\
Source: ClinicalTrials.gov (NCT03581773). StuddyBuddy aggregates publicly available trial information.
