Folic acid supplement for treating mucositis in metastatic renal cell carcinoma patients
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)
This study is testing if folic acid supplements can help reduce mouth sores in patients with advanced kidney cancer who are receiving treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Aarhus, Central Region of Denmark and 1 other locations) |
| Trial ID | NCT03581773 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of folic acid supplements in reducing mucositis adverse events in patients with metastatic renal cell carcinoma (mRCC) undergoing targeted therapy. It is a randomized, double-blind, placebo-controlled phase II trial where participants will receive either folic acid or a placebo for 12 weeks while also receiving best supportive care. The study aims to enroll 100 patients, with 50 in each treatment group, and will assess the degree of mucositis based on CTCAE grading. The trial is conducted by the Danish renal cancer group and anticipates a total accrual period of 96 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven inoperable, locally advanced, or metastatic renal cell carcinoma who are experiencing moderate to severe mucositis.
Not a fit: Patients with known hypersensitivity to folic acid will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate mucositis symptoms in patients undergoing therapy for metastatic renal cell carcinoma.
How similar studies have performed: While this approach is novel in the context of mRCC, similar studies have shown potential benefits of folic acid in managing mucositis in other cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus, Central Region of Denmark and 1 other locations
- Aarhus University Hospital, Department of oncology — Aarhus, Central Region of Denmark, Denmark (Recruiting)
- Department of Oncology, Herlev Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Niels Fristrup, MD PhD
- Email: niels.fristrup@rm.dk
- Phone: 004520914161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.