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)

Uncategorized

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: Mucositis

Intervention:

  • Drug: Folic Acid
  • Drug: Placebo Oral Tablet

Purpose: 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

Clinical Trials Identifier NCT 8-digits: NCT03581773

Sponsor: Frede Donskov

Primary Outcome Measures:

  • Measure: CTCAE Mucositis
  • Time Frame: 16 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: PRO Mucositis frequency
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Time to effect on mucositis
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Dose reductions
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Treatment discontinuations
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Treatment withdrawals
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: GI adverse events degree
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Hand-foot syndrome degree
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: QOL NCCN
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: PRO Mucositis degree
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: GI adverse events frequency
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Hand-foot syndrome frequency
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: QOL MDASI
  • Time Frame: 16 weeks
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: December 20, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 ≥
  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.

Contact:

  • Frede Donskov, MD DMSc
  • 004527147015

Locations:

  • Aarhus University Hospital, Department of oncology
  • Aarhus Central Region Of Denmark 8000 Denmark
  • Department of Oncology, Herlev Hospital
  • Herlev 2730 Denmark
  • Department of Oncology, Odense University Hospital
  • Odense 5000 Denmark

View trial on ClinicalTrials.gov

X