Mucositis, Stomatitis
Conditions
Brief 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)
Detailed description
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.
Interventions
DRUGFolic Acid
5 mg pr day for 12 weeks
DRUGPlacebo Oral Tablet
1 placebo pill pr day for 12 weeks
Sponsors
Niels Fristrup
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The master randomization list will be created, maintained and kept in a locked, secure location at Hospitalsapoteket Region Midtjylland, Afdeling Herning. The randomization list will not be available to any person directly involved in the study, including the study centre personnel or the project team. Randomization will be performed via a central randomization service available in business hours on working days by fax 7843 5165. A block design randomization procedure will be used.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTCAE Mucositis | 16 weeks | The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PRO Mucositis frequency | 16 weeks | 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 to effect on mucositis | 16 weeks | The median time to effect of study drug according to CTCAE 4.0 and PRO. |
| Dose reductions | 16 weeks | The frequency of TKI/mTOR dose reductions in the two groups |
| Treatment discontinuations | 16 weeks | The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups |
| Treatment withdrawals | 16 weeks | The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups |
| GI adverse events degree | 16 weeks | The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO. |
| Hand-foot syndrome degree | 16 weeks | The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO. |
| QOL NCCN | 16 weeks | The quality of life in the two groups according to NCCN-FACT FKSI-19. |
| PRO Mucositis degree | 16 weeks | 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. |
| GI adverse events frequency | 16 weeks | The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO. |
| Hand-foot syndrome frequency | 16 weeks | The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO. |
| QOL MDASI | 16 weeks | The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC. |
Countries
Denmark
Contacts
CONTACTNiels Fristrup, MD PhD
Outcome results
None listed