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

April 22, 2020 updated by: Frede Donskov

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Not yet recruiting
        • Department of Oncology, Herlev Hospital
        • Contact:
        • Sub-Investigator:
          • Anne Kirstine Moeller, MD PhD
      • Odense, Denmark, 5000
        • Not yet recruiting
        • Department of Oncology, Odense University Hospital
    • Central Region Of Denmark
      • Aarhus, Central Region Of Denmark, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital, Department of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Treatment arm
5 mg of folic acid (1 tablet) per day for 12 weeks.
Drug: Folic Acid
5 mg pr day for 12 weeks
PLACEBO_COMPARATOR: Placebo arm
PLACEBO (1 tablet) per day for 12 weeks.
Drug: Placebo Oral Tablet
1 placebo pill pr day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRO Mucositis frequency
Time Frame: 16 weeks
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.
16 weeks
Time to effect on mucositis
Time Frame: 16 weeks
The median time to effect of study drug according to CTCAE 4.0 and PRO.
16 weeks
Dose reductions
Time Frame: 16 weeks
The frequency of TKI/mTOR dose reductions in the two groups
16 weeks
Treatment discontinuations
Time Frame: 16 weeks
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups
16 weeks
Treatment withdrawals
Time Frame: 16 weeks
The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups
16 weeks
GI adverse events degree
Time Frame: 16 weeks
The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
16 weeks
Hand-foot syndrome degree
Time Frame: 16 weeks
The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
16 weeks
QOL NCCN
Time Frame: 16 weeks
The quality of life in the two groups according to NCCN-FACT FKSI-19.
16 weeks
PRO Mucositis degree
Time Frame: 16 weeks
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.
16 weeks
GI adverse events frequency
Time Frame: 16 weeks
The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.
16 weeks
Hand-foot syndrome frequency
Time Frame: 16 weeks
The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.
16 weeks
QOL MDASI
Time Frame: 16 weeks
The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frede Donskov

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2017

Primary Completion (ANTICIPATED)

December 20, 2021

Study Completion (ANTICIPATED)

December 20, 2022

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (ACTUAL)

July 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DARENCA 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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