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Study on Preventing Hypothyroidism in Patients with Medulloblastoma and Pediatric Lymphoma Using Levothyroxine During Radiation Therapy

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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 studying the effects of radiation therapy on the thyroid gland in patients with medulloblastoma, Hodgkin lymphoma, and non-Hodgkin lymphoma. These are types of cancers that may require radiation treatment near the thyroid gland, which can sometimes lead to a condition called hypothyroidism. Hypothyroidism occurs when the thyroid gland does not produce enough hormones, which can affect various body functions.

The study aims to find out if using a medication called Levothyroxine can help reduce the risk of developing hypothyroidism after radiation therapy. Levothyroxine is a medication that helps to replace or supplement the hormones that the thyroid gland usually produces. In this study, some patients will receive Levothyroxine during their radiation treatment, while others will not, to see if it makes a difference in preventing hypothyroidism.

Participants in the study will be monitored for three years after their radiation therapy to check for signs of hypothyroidism. The goal is to determine if Levothyroxine can help protect the thyroid gland during radiation treatment and improve the long-term health of patients with these types of cancer. This research is important for finding better ways to manage the side effects of cancer treatments and improve the quality of life for patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing written informed consent. This consent is necessary before any study-specific analysis or data collection can occur.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes verifying the absence of previous primary or secondary hypothyroidism and ensuring the patient has medulloblastoma, Hodgkin, or non-Hodgkin lymphoma before planning radiation therapy that includes the thyroid area.
Step 3
Treatment allocation
Patients are randomly assigned to one of two groups: one receiving only radiation therapy and the other receiving radiation therapy combined with levothyroxine treatment.
Step 4
Medication administration
For those in the combined treatment group, levothyroxine is administered orally in the form of a tablet. The specific dosage is 25 micrograms per tablet. The frequency and duration of administration are determined by the study protocol and medical team.
Step 5
Radiation therapy
Radiation therapy is conducted on the thyroid site as part of the treatment for medulloblastoma, Hodgkin, or non-Hodgkin lymphoma.
Step 6
Monitoring and follow-up
Patients are monitored for the onset of hypothyroidism. This involves regular blood tests to measure thyroid-stimulating hormone (TSH) levels. Monitoring continues for up to three years after the start of radiation therapy.
Step 7
Study completion
The primary endpoint is hypothyroidism-free survival at three years post-radiotherapy. The study aims to determine if TSH suppression during irradiation reduces the incidence of hypothyroidism.

Who can join the trial?

6 criteria

The patient must have one of the following conditions: medulloblastoma, Hodgkin lymphoma, or non-Hodgkin lymphoma. These are types of cancers that affect the brain or the lymphatic system.
The patient must be in the stage before starting radiotherapy (a treatment using high-energy rays to kill cancer cells) that includes the thyroid gland area.
The patient must not have had any previous primary or secondary hypothyroidism (a condition where the thyroid gland does not produce enough hormones).
The patient must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
The study is open to both male and female patients.
The study includes patients of various age groups, including children, adolescents, and adults.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with **Hodgkin lymphoma**, **non-Hodgkin lymphoma**, or **medulloblastoma** cannot participate. These are specific types of cancers.
Patients who are not within the specified age range cannot participate. The age range includes children and young adults.
Both **male** and **female** patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a **vulnerable population** are not excluded. This means the study is open to a wide range of participants.

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Verified sites

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Fondazione I.R.C.C.S. Istituto Neurologico Besta
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Milan, Italy

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Investigated drugs

Levothyroxine is a medication used in this trial to help protect the thyroid gland during radiation therapy. It works by suppressing the production of thyroid-stimulating hormone (TSH), which may help reduce the risk of developing hypothyroidism, a condition where the thyroid does not produce enough hormones. This medication is being tested to see if it can lower the chances of hypothyroidism in patients receiving radiation treatment for medulloblastoma, Hodgkin lymphoma, and non-Hodgkin lymphoma.

Levothyroxine

What is already known about the treatment

Levothyroxine – Levothyroxine is administered orally in tablet form and is used to manage thyroid hormone levels in the body. It is currently well-established in medical literature as a treatment for hypothyroidism and is being studied for its potential to reduce radiation-induced hypothyroidism in patients with medulloblastoma and lymphomas. The main therapeutic indication is to maintain normal thyroid function by supplementing or replacing thyroid hormones. At the molecular level, levothyroxine works by mimicking the natural thyroid hormone, thyroxine, which regulates metabolism and energy production in cells. It is classified as a thyroid hormone replacement therapy.

Investigated diseases

Hodgkin Lymphoma
This is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body's ability to fight infections.
Non-Hodgkin Lymphoma
This is a diverse group of blood cancers that include any kind of lymphoma except Hodgkin's lymphomas. It typically starts in the lymph nodes but can also affect other organs. The disease is characterized by the uncontrolled growth of lymphocytes, a type of white blood cell. Symptoms can include swollen lymph nodes, fever, night sweats, and unexplained weight loss. The progression can vary greatly depending on the specific type and stage of the disease.
Medulloblastoma
This is a type of brain cancer that is most common in children. It originates in the cerebellum, the part of the brain that controls balance and coordination. The tumor can spread to other parts of the brain and spinal cord through the cerebrospinal fluid. Symptoms may include headaches, nausea, vomiting, and problems with coordination or balance. As the tumor grows, it can increase pressure within the skull, leading to more severe symptoms.