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Compares treatment options for Mucositis
Official title Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy
ClinicalTrials.gov ID: NCT03581773
What this study is testing
What is Folic Acid?
Folic Acid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mucositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.
- 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.
You likely can't join if
- Known hypersensitivity to folic acid.
- Use of prednisolone more than 10 mg daily.
See the full eligibility criteria
- Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.
- 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...
- Karnofsky Performance status ≥ 60%.
- Known hypersensitivity to folic acid.
- Use of prednisolone more than 10 mg daily.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Central Region of Denmark, Denmark
- Herlev, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Central Region of Denmark, Denmark; Herlev, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.