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

Primary Purpose

Mucositis

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Folic Acid
Placebo Oral Tablet
Sponsored by
Frede Donskov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.

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%.

Exclusion Criteria:

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

Sites / Locations

  • Aarhus University Hospital, Department of oncologyRecruiting
  • Department of Oncology, Herlev Hospital
  • Department of Oncology, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment arm

Placebo arm

Arm Description

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

PLACEBO (1 tablet) per day for 12 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Time to effect on mucositis
The median time to effect of study drug according to CTCAE 4.0 and PRO.
Dose reductions
The frequency of TKI/mTOR dose reductions in the two groups
Treatment discontinuations
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups
Treatment withdrawals
The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups
GI adverse events degree
The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Hand-foot syndrome degree
The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
QOL NCCN
The quality of life in the two groups according to NCCN-FACT FKSI-19.
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.
GI adverse events frequency
The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Hand-foot syndrome frequency
The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
QOL MDASI
The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC.

Full Information

First Posted
May 7, 2018
Last Updated
April 22, 2020
Sponsor
Frede Donskov
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1. Study Identification

Unique Protocol Identification Number
NCT03581773
Brief Title
Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy
Acronym
FASTERCC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frede Donskov

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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)
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 24-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Active Comparator
Arm Description
5 mg of folic acid (1 tablet) per day for 12 weeks.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
PLACEBO (1 tablet) per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
5 mg pr day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
1 placebo pill pr day for 12 weeks
Primary Outcome Measure Information:
Title
CTCAE Mucositis
Description
The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
PRO Mucositis frequency
Description
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.
Time Frame
16 weeks
Title
Time to effect on mucositis
Description
The median time to effect of study drug according to CTCAE 4.0 and PRO.
Time Frame
16 weeks
Title
Dose reductions
Description
The frequency of TKI/mTOR dose reductions in the two groups
Time Frame
16 weeks
Title
Treatment discontinuations
Description
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups
Time Frame
16 weeks
Title
Treatment withdrawals
Description
The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups
Time Frame
16 weeks
Title
GI adverse events degree
Description
The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Time Frame
16 weeks
Title
Hand-foot syndrome degree
Description
The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
Time Frame
16 weeks
Title
QOL NCCN
Description
The quality of life in the two groups according to NCCN-FACT FKSI-19.
Time Frame
16 weeks
Title
PRO Mucositis degree
Description
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.
Time Frame
16 weeks
Title
GI adverse events frequency
Description
The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
Time Frame
16 weeks
Title
Hand-foot syndrome frequency
Description
The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
Time Frame
16 weeks
Title
QOL MDASI
Description
The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma. Inclusion Criteria: 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%. Exclusion Criteria: Known hypersensitivity to folic acid. Use of prednisolone more than 10 mg daily.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frede Donskov, MD DMSc
Phone
004527147015
Email
Frede.Donskov@auh.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Niels Fristrup, MD PhD
Phone
004520914161
Email
niels.fristrup@rm.dk
Facility Information:
Facility Name
Aarhus University Hospital, Department of oncology
City
Aarhus
State/Province
Central Region Of Denmark
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frede Donskov, MD DMSc
Phone
004527147015
Email
Frede.Donskov@auh.rm.dk
First Name & Middle Initial & Last Name & Degree
Niels Fristrup, MD PhD
Phone
004520914161
Email
niels.fristrup@rm.dk
Facility Name
Department of Oncology, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Palshof, MD, PhD
Phone
+45 38683868
Email
Jesper.Andreas.Palshof@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anne Kirstine Moeller, MD PhD
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Viggo Jensen, MD
Phone
+45 6611 3333
Email
Niels.Viggo.Jensen@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31101577
Citation
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.
Results Reference
derived

Learn more about this trial

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

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