Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy (FASTERCC)
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- STATUS
- Recruiting
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- End date
- Dec 20, 2022
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- participants needed
- 100
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- sponsor
- Frede Donskov
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)
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 24-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.
Details
| Condition | Mucositis |
|---|---|
| Treatment | Folic acid, Placebo Oral Tablet |
| Clinical Study Identifier | NCT03581773 |
| Sponsor | Frede Donskov |
| Last Modified on | 5 March 2022 |
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