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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2028-12-20

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Mucositis Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Treatment arm

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

Group Type ACTIVE_COMPARATOR

Folic Acid

Intervention Type DRUG

5 mg pr day for 12 weeks

Placebo arm

PLACEBO (1 tablet) per day for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

1 placebo pill pr day for 12 weeks

Interventions

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Folic Acid

5 mg pr day for 12 weeks

Intervention Type DRUG

Placebo Oral Tablet

1 placebo pill pr day for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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%.