Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy

Launched by NIELS FRISTRUP · Jul 9, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether taking a folic acid supplement can help reduce mouth sores (called mucositis) in patients with advanced kidney cancer who are undergoing targeted therapy, which is a special type of cancer treatment. The trial is being conducted by the Danish renal cancer group and is currently looking for participants. To join the study, patients must be at least 18 years old and have a confirmed diagnosis of advanced or metastatic renal cell carcinoma, along with moderate to severe mucositis related to their treatment. Women who can become pregnant need to use effective birth control during the study.

If you decide to participate, you will be randomly assigned to either receive the folic acid supplement or a placebo, which is a non-active pill that looks the same but has no medicine in it. Throughout the trial, you will be monitored to see if the folic acid has any effect on your mouth sores. Your safety is a priority, and you'll need to provide informed consent before starting. This study offers a chance to help improve care for others with similar conditions while also potentially benefiting your own treatment experience.

Gender

ALL

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.