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

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ClinicalTrials.gov Identifier: NCT03581773
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Frede Donskov, Aarhus University Hospital

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)

Condition or disease Intervention/treatment Phase
Mucositis Drug: Folic Acid Drug: Placebo Oral Tablet Phase 2

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose: Treatment
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)
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2020


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Time to effect on mucositis [ Time Frame: 16 weeks ]
    The median time to effect of study drug according to CTCAE 4.0 and PRO.

  3. Dose reductions [ Time Frame: 16 weeks ]
    The frequency of TKI/mTOR dose reductions in the two groups

  4. Treatment discontinuations [ Time Frame: 16 weeks ]
    The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups

  5. Treatment withdrawals [ Time Frame: 16 weeks ]
    The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups

  6. 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.

  7. 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.

  8. QOL NCCN [ Time Frame: 16 weeks ]
    The quality of life in the two groups according to NCCN-FACT FKSI-19.

  9. 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.

  10. 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.

  11. 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.

  12. QOL MDASI [ Time Frame: 16 weeks ]
    The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581773


Contacts
Contact: Frede Donskov, MD DMSc 004527147015 Frede.Donskov@auh.rm.dk
Contact: Niels Fristrup, MD PhD 004520914161 niels.fristrup@rm.dk

Locations
Denmark
Aarhus University Hospital, Department of oncology Recruiting
Aarhus, Central Region Of Denmark, Denmark, 8000
Contact: Frede Donskov, MD DMSc    004527147015    Frede.Donskov@auh.rm.dk   
Contact: Niels Fristrup, MD PhD    004520914161    niels.fristrup@rm.dk   
Department of Oncology, Herlev Hospital Not yet recruiting
Herlev, Denmark, 2730
Contact: Poul Geertsen, MD, PhD    +45 4488 4488    Poul.Geertsen@regionh.dk   
Sub-Investigator: Anne Kirstine Moeller, MD PhD         
Department of Oncology, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Niels Viggo Jensen, MD    +45 6611 3333    Niels.Viggo.Jensen@rsyd.dk   
Sponsors and Collaborators
Frede Donskov

Responsible Party: Frede Donskov, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03581773     History of Changes
Other Study ID Numbers: DARENCA 4
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Mucositis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs