Study on Digoxin and Sodium Iodide (123 I) for Patients with Advanced Non-Medullary Thyroid Cancer

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What is this study about?

This clinical trial is focused on studying the effects of the medication digoxin in patients with a type of thyroid cancer known as non-medullary thyroid carcinoma (NMTC). This cancer can be locally advanced or have spread to other parts of the body, which is referred to as metastatic. The study aims to see if digoxin can help these patients by improving the uptake of a treatment called radioiodine (RaI), which is sometimes not absorbed well by the cancer cells in these patients.

Participants in the study will receive digoxin, which is a medication commonly used to treat heart conditions, in the form of a tablet. Additionally, some participants may receive an injection of sodium iodide (I123), which is a type of radioiodine used in medical imaging. The study will compare the effects of digoxin with a placebo to determine if it helps increase the absorption of radioiodine in the cancer cells. The study will last for a few months, during which participants will undergo regular check-ups and tests to monitor their response to the treatment.

The main goal of the study is to find out if digoxin can help patients with NMTC who have not responded well to previous radioiodine treatments. Researchers will look at how many patients show improved uptake of radioiodine in their cancer cells. They will also assess the overall response to the treatment, any side effects, and the quality of life of the participants. This information will help determine if digoxin can be a beneficial addition to the treatment of non-medullary thyroid carcinoma.

1 initial assessment

Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of non-medullary thyroid carcinoma (NMTC), age of 18 years or older, and previous treatments such as total thyroidectomy and at least one treatment with radioactive iodine (RaI).

The presence of local or metastatic disease is confirmed through imaging, ensuring at least one target lesion is present. The lesion must not be eligible for local treatments like radiotherapy.

2 medication administration

Participants receive digoxin in the form of a tablet, known as Lanoxin 125, with a dosage of 0.125 mg. This medication is taken orally.

Additionally, sodium iodide (I123) is administered as an intravenous injection, with a concentration of 37 MBq/ml. The frequency and duration of administration are determined by the study protocol.

3 monitoring and assessments

Regular monitoring is conducted to assess the reinduction of RaI uptake in target lesions. This is evaluated using RaI scintigraphy, a type of imaging test.

Participants are also assessed for their response to RaI treatment after six months, using criteria such as RECIST for tumor response and thyroglobulin levels for biochemical response.

4 safety and quality of life evaluations

Safety assessments are performed to monitor any potential side effects, using established criteria for evaluating toxicity.

Quality of life is evaluated using a standardized questionnaire, the EORTC QLQ-C30, to understand the impact of the treatment on daily living.

5 end of trial

The trial is expected to conclude by September 1, 2024. At the end of the trial, final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Being diagnosed with non-medullary thyroid carcinoma (NMTC).
Being aged 18 years or older.
Having undergone a total thyroidectomy (surgical removal of the thyroid gland) and at least one treatment with Radioactive Iodine (RaI).
Having local or metastatic disease (cancer that has spread to other parts of the body), which is confirmed by imaging tests. There must be at least one target lesion, which is a specific area of cancer that can be measured, with a minimum size of 1.0 cm for soft tissue and 1.5 cm for lymph nodes.
Having RaI refractory disease, meaning at least one target lesion does not show significant RaI uptake on previous scans, indicating that the cancer does not respond to RaI treatment.
The target lesion must not be suitable for local treatments like radiotherapy or radiofrequency ablation. If there are multiple lesions, local treatment is allowed, but these treated lesions are not considered target lesions for the study.

Who Cannot Join the Study?

Patients with other types of thyroid cancer that are not non-medullary thyroid carcinoma (NMTC) cannot participate.
Patients who are not able to take the study medication, digoxin, cannot participate.
Patients who have a known allergy to digoxin or any of its ingredients cannot participate.
Patients who have a serious heart condition that makes it unsafe to take digoxin cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are participating in another clinical trial at the same time cannot participate.
Patients who have a medical condition that the study doctors believe would make it unsafe to participate cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Stichting Radboud University Medical Center	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.09.2022

Trial locations

Investigated drugs:

Digoxin is a medication that is being studied for its potential benefits in patients with a type of thyroid cancer called non-medullary thyroid carcinoma. This cancer can be locally advanced or have spread to other parts of the body. The main goal of using digoxin in this trial is to see if it can help the body take up more radioactive iodine, which is often used in treating this type of cancer. By increasing the uptake of radioactive iodine, digoxin may help make the treatment more effective for patients who have not been responding well to it.

Investigated diseases:

Thyroid cancer metastatic

Non-medullary thyroid carcinoma – Non-medullary thyroid carcinoma is a type of thyroid cancer that arises from the follicular cells of the thyroid gland. It is distinct from medullary thyroid carcinoma, which originates from parafollicular C cells. This disease can manifest as a solitary nodule or multiple nodules in the thyroid gland. As it progresses, it may spread to nearby lymph nodes and, in advanced cases, to distant organs such as the lungs and bones. The disease is characterized by its ability to grow and invade surrounding tissues, potentially leading to symptoms such as a lump in the neck, difficulty swallowing, or changes in voice. The progression of non-medullary thyroid carcinoma can vary, with some cases remaining localized while others become more aggressive and metastatic.

Trial ID:

2022-500477-14-00

Protocol code:

113327

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Digoxin and Sodium Iodide (123 I) for Patients with Advanced Non-Medullary Thyroid Cancer

What is this study about?

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