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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    100
  • sponsor
    Frede Donskov
Updated on 24 January 2021
cancer
hysterectomy
metastatic renal cell carcinoma

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 Gastroenteritis, Gastroenteritis, Mucositis, Mucositis, mucosal inflammation
Treatment Folic acid, Placebo Oral Tablet
Clinical Study IdentifierNCT03581773
SponsorFrede Donskov
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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%

Exclusion Criteria

Known hypersensitivity to folic acid
Use of prednisolone more than 10 mg daily
Clear my responses

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