Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy (DARENCA4)

Niels Fristrup

Status and phase: Enrolling; Phase 2

Conditions: Stomatitis; Mucositis

Treatments: Drug: Folic Acid; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03581773

FASTERCC

Details and patient eligibility

About

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)

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Treatment arm

Active Comparator group

Description:

5 mg of folic acid (1 tablet) per day for 12 weeks.

Treatment:

Drug: Folic Acid

Placebo arm

Placebo Comparator group

Description:

PLACEBO (1 tablet) per day for 12 weeks.

Treatment:

Drug: Placebo Oral Tablet