NCT03581773

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
40mo left

Started Dec 2017

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Dec 2017Sep 2029

Study Start

First participant enrolled

December 20, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

8.7 years

First QC Date

May 7, 2018

Last Update Submit

April 28, 2026

Conditions

MucositisStomatitis

Outcome Measures

Primary Outcomes (1)

  • CTCAE Mucositis

    The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).

    16 weeks

Secondary Outcomes (12)

  • PRO Mucositis frequency

    16 weeks

  • Time to effect on mucositis

    16 weeks

  • Dose reductions

    16 weeks

  • Treatment discontinuations

    16 weeks

  • Treatment withdrawals

    16 weeks

  • +7 more secondary outcomes

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

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

Drug: Folic Acid

Placebo arm

PLACEBO COMPARATOR

PLACEBO (1 tablet) per day for 12 weeks.

Drug: Placebo Oral Tablet

Interventions

Folic AcidDRUG

5 mg pr day for 12 weeks

Treatment arm
Placebo Oral TabletDRUG

1 placebo pill pr day for 12 weeks

Placebo arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital, Department of oncology

Aarhus, Central Region of Denmark, 8000, Denmark

RECRUITING

Department of Oncology, Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Related Publications (1)

  • Fristrup N, Donskov F. Folic Acid Reduces Mucositis in Metastatic Renal Cell Carcinoma Patients: A Retrospective Study. Clin Genitourin Cancer. 2019 Aug;17(4):254-259. doi: 10.1016/j.clgc.2019.03.023. Epub 2019 Apr 6.

    PMID: 31101577DERIVED

MeSH Terms

Conditions

MucositisStomatitis

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Niels Fristrup, MD PhD

CONTACT

004520914161niels.fristrup@rm.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2018

First Posted

July 10, 2018

Study Start

December 20, 2017

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2029

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations

DK(2)