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)
Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI, immunotherapy or mTOR inhibitor treatment in mRCC patients. The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor treatment or immunotherapy and displaying CTCAE mucositis grade ≥2 can reduce the degree of mucositis, compared to PLACEBO. This is a randomized, double-blind, placebo-controlled phase II trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. Both arms will receive best supportive care. No crossover is allowed. The investigators anticipate a 96-month accrual period. The power calculation indicates a total of 50 patients per group are required. Block randomization based on received TKI/ mTOR inhibitor/IT-treatment will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
5 mg pr day for 12 weeks
1 placebo pill pr day for 12 weeks
Aarhus University Hospital, Department of oncology
Aarhus, Central Region of Denmark, Denmark
Department of Oncology, Herlev Hospital
Herlev, Herlev, Denmark
CTCAE Mucositis
The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).
Time frame: 16 weeks
PRO Mucositis frequency
The frequency of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.
Time frame: 16 weeks
Time to effect on mucositis
The median time to effect of study drug according to CTCAE 4.0 and PRO.
Time frame: 16 weeks
Dose reductions
The frequency of TKI/mTOR dose reductions in the two groups
Time frame: 16 weeks
Treatment discontinuations
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups
Time frame: 16 weeks
Treatment withdrawals
The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups
Time frame: 16 weeks
GI adverse events degree
The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Time frame: 16 weeks
Hand-foot syndrome degree
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The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
Time frame: 16 weeks
QOL NCCN
The quality of life in the two groups according to NCCN-FACT FKSI-19.
Time frame: 16 weeks
PRO Mucositis degree
The degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.
Time frame: 16 weeks
GI adverse events frequency
The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Time frame: 16 weeks
Hand-foot syndrome frequency
The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
Time frame: 16 weeks
QOL MDASI
The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC.
Time frame: 16 weeks