Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT03581773

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

Led by Niels Fristrup · Updated on 2026-05-04

100

Participants Needed

2

Research Sites

610 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with inoperable, locally advanced, or metastatic renal cell carcinoma confirmed by biopsy
  • Displaying CTCAE grade 2 or higher mucositis during TKI, mTOR inhibitor, or immunotherapy treatment
  • Signed written informed consent before any study procedures
  • Age 18 years or older
  • Females with negative serum pregnancy test unless childbearing potential is excluded (postmenopausal, hysterectomy, or oophorectomy) and not breastfeeding
  • Fertile women of childbearing potential and men must use effective contraception
  • Karnofsky Performance Status of 60% or higher
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to folic acid
  • Use of prednisolone more than 10 mg daily

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Aarhus University Hospital, Department of oncology

Aarhus, Central Region of Denmark, Denmark, 8000

Actively Recruiting

2

Department of Oncology, Herlev Hospital

Herlev, Denmark, 2730

Actively Recruiting

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Research Team

N

Niels Fristrup, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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