Folic acid supplement versus placebo for treating side effects due to cancer treatment in metastatic renal cell carcinoma (FASTERCC). A Danish renal cancer group study (DARENCA-4).

Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy (FASTERCC). A randomized, double-blind, phase II trial from the Danish renal cancer group (DARENCA study-4). - Folic Acid Supplement for Treating adverse Events in metastatic Renal Cell Carcinoma (FASTERCC).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001193-15-DK

Enrollment

100

Registered

2016-05-18

Start date

2016-07-06

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI and mTOR inhibitor treatment of metastatic renal cell carcinoma patients. The present trial will assess whether a complementary treatment with folic acid in patients displaying mucositis =2 based on the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) can reduce the degree of mucositis, compared to PLACEBO. MedDRA version: 21.1 Level: LLT Classification code 10064282 Term: Vaginal mucositi

Interventions

Trade Name: Folimet Product Name: Folimet Pharmaceutical Form: Tablet INN or Proposed INN: pteroylglutamate Other descriptive name: FOLIC ACID Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients displaying CTCAE =2 mucositis during TKI or mTOR inhibitor 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 ( 60%. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Known hypersensitivity to folic acid

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to evaluate the effectiveness of folic acid supplement versus PLACEBO on reducing mucositis (nasal, oral, pharyngeal, anal, or genital) according to CTCAE v. 4.0. Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI and mTOR inhibitor treatment of mRCC patients. The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor-treatment and displaying CTCAE mucositis grade =2 can reduce the degree of mucositis, compared to PLACEBO. ;Secondary Objective: •To evaluate mucositis according to patient reported outcomes (PRO) by self assessment questionnaire (the NCCN-FKSI-19, and an extended version of the M.D. Anderson Symptom Inventory). •To evaluate the median time to effect of study drug according to CTCAE v 4.0 and PRO. •To evaluate the frequency of dose reductions in the two groups. •To evaluate the frequency of treatment discontinuations in the two groups. •To evaluate the frequency of treatment withdrawals in the two groups. •To evaluate the frequency and degree of GI adverse events according to CTCAE v 4.0 and PRO. •To evaluate the frequency and degree of hand-foot according to CTCAE v 4.0 and PRO. •To evaluate the quality of life according to CTCAE v 4.0 and PRO. •To evaluate the degree of TKI- and mTOR inhibitor-specific adverse events according to CTCAE v 4.0 and PRO.;Primary end point(s): The primary endpoint is change from baseline mocositis score according to CTCAE v. 4.0. Degree of CTCAE scored mucositis (oral, pharyngeal, anal, or genital) scored on schedules visits at baseline, day 28, day 56, and day 84 using the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE). Mean difference in change from baseline will be presented for the two groups, using a mean-comparison test on paired data.;Timepoint(s) of evaluation of this end point: Median time to effect of folic acid supplement	—

Measure

Time frame

Main Objective: The primary objective of the trial is to evaluate the effectiveness of folic acid supplement versus PLACEBO on reducing mucositis (nasal, oral, pharyngeal, anal, or genital) according to CTCAE v. 4.0. Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI and mTOR inhibitor treatment of mRCC patients. The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor-treatment and displaying CTCAE mucositis grade =2 can reduce the degree of mucositis, compared to PLACEBO. ;Secondary Objective: •To evaluate mucositis according to patient reported outcomes (PRO) by self assessment questionnaire (the NCCN-FKSI-19, and an extended version of the M.D. Anderson Symptom Inventory). •To evaluate the median time to effect of study drug according to CTCAE v 4.0 and PRO. •To evaluate the frequency of dose reductions in the two groups. •To evaluate the frequency of treatment discontinuations in the two groups. •To evaluate the frequency of treatment withdrawals in the two groups. •To evaluate the frequency and degree of GI adverse events according to CTCAE v 4.0 and PRO. •To evaluate the frequency and degree of hand-foot according to CTCAE v 4.0 and PRO. •To evaluate the quality of life according to CTCAE v 4.0 and PRO. •To evaluate the degree of TKI- and mTOR inhibitor-specific adverse events according to CTCAE v 4.0 and PRO.;Primary end point(s): The primary endpoint is change from baseline mocositis score according to CTCAE v. 4.0. Degree of CTCAE scored mucositis (oral, pharyngeal, anal, or genital) scored on schedules visits at baseline, day 28, day 56, and day 84 using the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE). Mean difference in change from baseline will be presented for the two groups, using a mean-comparison test on paired data.;Timepoint(s) of evaluation of this end point: Median time to effect of folic acid supplement

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Secondary

Measure	Time frame
Secondary end point(s): Change from baseline GI adverse events based on CTCAE v. 4.0 or PRO. Change from baseline hand-foot syndrome based on CTCAE v. 4.0 or PRO. Change from baseline Quality of Life (QoL) based on CTCAE v. 4.0 or PRO. The median time to effect of study drug will be evaluated based on PRO every week of the 12 weeks study period. The frequency of dose reductions in the two groups after the 12 week study period will be evaluated. The frequency of treatment discontinuations in the two groups after the 12 week study period will be evaluated. The frequency of treatment withdrawals in the two groups after the 12 week study period will be evaluated.;Timepoint(s) of evaluation of this end point: Median time to effect of folic acid supplement will be calculated, this defined as time to a 2-point reduced mucositis, scored on a scale from 0-10, adapted from the MD Anderson Symptom Inventory. Kaplan-Meier analysis of time to a 2-point reduction in both mucositis, GI adverse events, and hand-foot syndrome will be calculated, together with a P-value based on log-rank test. The median reduction in 0-10 scoring from baseline will be calculated for the two groups. Response rates, rates of CTCAE adverse events, rates of dose reductions, rates of discontinuations, and rates of treatment withdrawals will be compared using ?2 or Fisher’s exact test. Quality of life comparisons will be based on Wilcoxon rank sum test. All reported p-values will be 2-sided.	—

Measure

Time frame

Secondary end point(s): Change from baseline GI adverse events based on CTCAE v. 4.0 or PRO. Change from baseline hand-foot syndrome based on CTCAE v. 4.0 or PRO. Change from baseline Quality of Life (QoL) based on CTCAE v. 4.0 or PRO. The median time to effect of study drug will be evaluated based on PRO every week of the 12 weeks study period. The frequency of dose reductions in the two groups after the 12 week study period will be evaluated. The frequency of treatment discontinuations in the two groups after the 12 week study period will be evaluated. The frequency of treatment withdrawals in the two groups after the 12 week study period will be evaluated.;Timepoint(s) of evaluation of this end point: Median time to effect of folic acid supplement will be calculated, this defined as time to a 2-point reduced mucositis, scored on a scale from 0-10, adapted from the MD Anderson Symptom Inventory. Kaplan-Meier analysis of time to a 2-point reduction in both mucositis, GI adverse events, and hand-foot syndrome will be calculated, together with a P-value based on log-rank test. The median reduction in 0-10 scoring from baseline will be calculated for the two groups. Response rates, rates of CTCAE adverse events, rates of dose reductions, rates of discontinuations, and rates of treatment withdrawals will be compared using ?2 or Fisher’s exact test. Quality of life comparisons will be based on Wilcoxon rank sum test. All reported p-values will be 2-sided.

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Countries

Denmark

Contacts

Public ContactNiels Fristrup MD PhD

Department of Oncology, Aarhus University Hospital

niels.fristrup@rm.dk004520914161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026