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

Inclusion Criteria9

• Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.
• Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.
• Signed written informed consent obtained prior to any study specific procedures.
• Patient must be willing and able to comply with the protocol.
• Age ≥ 18.
• Biopsy proven locally advanced or metastatic renal cell carcinoma.
• Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
• 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).
• Karnofsky Performance status ≥ 60%.