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Recruiting NCT03581773

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

Phase II Interventional Mucositis Stomatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Folic Acid, Placebo Oral Tablet.
Who it may be relevant to
Registry conditions: Mucositis, Stomatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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 96-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.

Interventions

  • Drug Folic Acid
    5 mg pr day for 12 weeks
  • Drug Placebo Oral Tablet
    1 placebo pill pr day for 12 weeks

Primary outcome measures

  • CTCAE Mucositis [Time frame: 16 weeks]
Secondary outcome measures (12)
  • PRO Mucositis frequency [Time frame: 16 weeks]
  • Time to effect on mucositis [Time frame: 16 weeks]
  • Dose reductions [Time frame: 16 weeks]
  • Treatment discontinuations [Time frame: 16 weeks]
  • Treatment withdrawals [Time frame: 16 weeks]
  • GI adverse events degree [Time frame: 16 weeks]
  • Hand-foot syndrome degree [Time frame: 16 weeks]
  • QOL NCCN [Time frame: 16 weeks]
  • PRO Mucositis degree [Time frame: 16 weeks]
  • GI adverse events frequency [Time frame: 16 weeks]
  • Hand-foot syndrome frequency [Time frame: 16 weeks]
  • QOL MDASI [Time frame: 16 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • Aarhus University Hospital, Department of oncology — Aarhus
  • Department of Oncology, Herlev Hospital — Herlev

Publications

  • 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. PMID 31101577

Identifiers

NCT: NCT03581773 · FASTERCC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗