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Study on Folic Acid for Reducing Mucositis in Patients with Metastatic Kidney Cancer Receiving Targeted Therapy

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. The study is investigating the effects of a folic acid supplement, known as Folimet, compared to a placebo. Folic acid is a type of vitamin B that is important for cell growth and metabolism. The main goal of the study is to see if folic acid can help reduce mucositis, which is a painful inflammation and ulceration of the mucous membranes lining the digestive tract, often caused by cancer treatments.

Participants in the study will receive either the folic acid supplement or a placebo. The study will monitor the degree of mucositis experienced by participants, using a standard set of criteria known as the Common Terminology Criteria for Adverse Events (CTCAE). The study will also collect information on how often and how severe the mucositis is, based on patient self-assessments. Additionally, the study will look at other factors such as the need for dose reductions or discontinuations of cancer treatments, and the overall quality of life of participants.

The trial is expected to run until 2026, and it aims to provide valuable insights into whether folic acid can be an effective way to manage mucositis in patients undergoing treatment for metastatic renal cell carcinoma. This could potentially improve the comfort and quality of life for patients dealing with this challenging side effect of cancer therapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have signed a written informed consent form. This confirms understanding and agreement to participate in the trial.
Eligibility criteria include being 18 years or older, having a biopsy-proven diagnosis of locally advanced or metastatic renal cell carcinoma, and a Karnofsky Performance status of 60% or higher.
Step 2
Initial assessment
An initial assessment is conducted to confirm the presence of mucositis, which is a side effect of cancer treatment affecting areas such as the mouth, throat, or genital region.
The severity of mucositis is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Step 3
Medication administration
The patient receives either a folic acid supplement or a placebo. The folic acid is administered in the form of a 5 mg tablet, taken orally.
The frequency and duration of the medication administration are determined by the study protocol.
Step 4
Ongoing monitoring
The patient is monitored regularly to assess the degree of mucositis and any other side effects.
Patient-reported outcomes are collected using questionnaires such as the 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 for renal cell carcinoma.
Step 5
Evaluation of treatment effects
The primary endpoint is the degree of mucositis according to CTCAE version 4.0.
Secondary endpoints include the frequency and degree of mucositis, the time to effect of the study drug, and the frequency of dose reductions or discontinuations of cancer treatment.
Step 6
Completion of the study
The study is estimated to end by May 1, 2026.
Upon completion, the data collected will be analyzed to determine the effectiveness of folic acid in reducing mucositis compared to the placebo.

Who can join the trial?

8 criteria

Patients must have **mucositis** (painful inflammation and sores) rated as grade 2 or higher during treatment with certain cancer drugs.
Patients need to sign a written consent form before any study procedures begin.
Patients must be willing and able to follow the study's rules and procedures.
Patients must be at least 18 years old.
Patients must have a confirmed diagnosis of **locally advanced** or **metastatic renal cell carcinoma** (a type of kidney cancer that has spread).
Females must have a negative pregnancy test unless they cannot become pregnant due to reasons like menopause, removal of the uterus (hysterectomy), or removal of the ovaries (oophorectomy), and they must not be breastfeeding.
Women who can become pregnant and men must use effective birth control methods, such as birth control pills, devices placed inside the uterus, barrier methods like condoms with spermicidal jelly, or surgical sterilization.
Patients must have a **Karnofsky Performance status** of 60% or higher, which means they can take care of themselves and do some activities, but might need help with more demanding tasks.

Who cannot join the trial?

4 criteria

Patients who do not have metastatic renal cell carcinoma (mRCC). This is a type of kidney cancer that has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Herlev Hospital
Herlev, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Folic Acid Supplement is being tested in this trial to see if it can help reduce mucositis, which is a condition that causes inflammation and sores in various parts of the body such as the mouth, throat, and other areas. This supplement is being given to patients who are receiving targeted therapy for metastatic renal cell carcinoma, a type of kidney cancer. The goal is to determine if folic acid can lessen the side effects of the cancer treatment.

Folic Acid

What is already known about the treatment

Folic Acid – Folic acid is administered orally in the form of tablets or capsules. It is currently being studied in clinical trials for its potential to reduce mucositis, a painful inflammation and ulceration of the mucous membranes, in patients with metastatic renal cell carcinoma receiving targeted therapy. The main therapeutic indication in this context is to alleviate mucositis symptoms. At the molecular level, folic acid works by aiding in the synthesis and repair of DNA, which may help in the regeneration of damaged mucosal tissues. It is classified as a vitamin, specifically a B vitamin, essential for various bodily functions.

Investigated diseases

Metastatic Renal Cell Carcinoma – This is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It often begins in the lining of the small tubes in the kidney and can spread to organs such as the lungs, bones, or liver. The disease progresses as cancer cells travel through the bloodstream or lymphatic system, forming new tumors in other organs. Symptoms may include blood in the urine, pain in the side or back, and unexplained weight loss. As the cancer spreads, it can cause additional symptoms depending on the organs affected. The progression of the disease can vary greatly among individuals.