MucositisPhase 2DARENCA4NCT03581773
Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy
A Phase 2 study testing Folic Acid in people with Mucositis and Stomatitis, run by Niels Fristrup at 2 sites in Denmark.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucositis, Stomatitis
- What is being tested?
- Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Dec 2017to 22 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- Known hypersensitivity to folic acid.
- Use of prednisolone more than 10 mg daily.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital, Department of oncology
Aarhus, Central Region of Denmark, 8000
Department of Oncology, Herlev Hospital
Herlev, Herlev, 2730
About this study
Official title: 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)
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)
Read the detailed 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.
- Conditions
- Mucositis, Stomatitis
- Being tested
- Folic Acid, Placebo Oral Tablet
- Medical subject headings
- Mucositis, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
5 mg pr day for 12 weeks
Placebo Oral TabletDrug
1 placebo pill pr day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | 5 mg of folic acid (1 tablet) per day for 12 weeks. Receives: Drug: Folic Acid |
| Placebo arm | Placebo comparator | PLACEBO (1 tablet) per day for 12 weeks. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16 weeks
Secondary outcomes (12)
PRO Mucositis frequency
The frequency of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.
Measured: 16 weeks
Time to effect on mucositis
The median time to effect of study drug according to CTCAE 4.0 and PRO.
Measured: 16 weeks
Dose reductions
The frequency of TKI/mTOR dose reductions in the two groups
Measured: 16 weeks
Treatment discontinuations
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups
Measured: 16 weeks
Treatment withdrawals
The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups
Measured: 16 weeks
GI adverse events degree
The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Measured: 16 weeks
Hand-foot syndrome degree
The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
Measured: 16 weeks
QOL NCCN
The quality of life in the two groups according to NCCN-FACT FKSI-19.
Measured: 16 weeks
PRO Mucositis degree
The degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.
Measured: 16 weeks
GI adverse events frequency
The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Measured: 16 weeks
Hand-foot syndrome frequency
The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
Measured: 16 weeks
QOL MDASI
The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start20 Dec 2017
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niels Fristrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niels Fristrup, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581773
- Sponsor's protocol ID
- FASTERCC
- Acronym
- DARENCA4
- Status last verified
- Sep 2026
- First submitted
- 7 May 2018
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31101577
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03581773
- Acronym / sponsor ID
- DARENCA4 / FASTERCC
- Conditions
- Mucositis, Stomatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Niels FristrupUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 22 Sep 2026 (actual)
- Study completion
- 22 Sep 2026 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Drug: Folic Acid5 mg of folic acid (1 tablet) per day for 12 weeks. |
| Placebo arm | Placebo comparator | Drug: Placebo Oral TabletPLACEBO (1 tablet) per day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Known hypersensitivity to folic acid.
- Use of prednisolone more than 10 mg daily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acid5 mg pr day for 12 weeks | Drug | Treatment arm |
| Placebo Oral Tablet1 placebo pill pr day for 12 weeks | Drug | Placebo arm |
Primary outcome
CTCAE Mucositis
Time frame: 16 weeks
The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).
12 secondary outcomes
PRO Mucositis frequency
Time frame: 16 weeks
Time to effect on mucositis
Time frame: 16 weeks
Dose reductions
Time frame: 16 weeks
Treatment discontinuations
Time frame: 16 weeks
Treatment withdrawals
Time frame: 16 weeks
GI adverse events degree
Time frame: 16 weeks
Hand-foot syndrome degree
Time frame: 16 weeks
QOL NCCN
Time frame: 16 weeks
PRO Mucositis degree
Time frame: 16 weeks
GI adverse events frequency
Time frame: 16 weeks
Hand-foot syndrome frequency
Time frame: 16 weeks
QOL MDASI
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Derived from this study: PubMed 31101577Fristrup 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Folic Acid in people with Mucositis and Stomatitis, run by Niels Fristrup at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTCAE Mucositis (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.