Neoplasms

All Conditions

Gland and Hormone Related Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma

Adenocarcinoma, Papillary

Anti-Arrhythmia Agents

Cardiotonic Agents

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Digoxin

Iodine

Cadexomer iodine

Enzyme Inhibitors

Protective Agents

This arm will consist of 10 patients with radioiodine refractory non-medullary thyroid carcinoma. All participants will be treated according to the same protocol.

Participants will be treated with digoxin tablets for 3 weeks. On the first they, participants will start with a starting dosage of 3x0.25mg with 6 hours between each administration. Thereafter they will continue with a dosage of 1x0.25mg. Participants aged \>70 years or with body weight \<55kg will initiate a starting dosage of 3x0.125mg with 6 hours between each administration. Thereafter they will continue with a dosage of 1x0.125mg.

After one week the blood concentration of digoxin will be measured. According to this blood concentration, the dose of digoxin will be adjusted.

Digoxin tablet

Non-medullary thyroid carcinoma has a good prognosis in most patients. However, a small subset of patients nevertheless develop metastatic or locally advanced and unresectable disease which in some cases also becomes radioiodine refractory. In these patients treatment options are very limited. Earlier cell line and animal studies have shown that digoxin can reinduce radioiodine uptake in non-medullary thyroid cancer. This study serves as a proof of principle study to assess the possibility of digoxin to reinduce radioiodine uptake in adult humans with metastatic or locally advanced non-medullary radioiodine refractory thyroid carcinoma.

10 participants with radioiodine refractory metastatic or locally advanced non-medullary thyroid carcinoma will enroll in this study. All participants will be treated according to the same protocol.

Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma

At baseline and after 3 weeks of digoxin treatment, a scintigraphy scan will be conducted. Reinduction of radioiodine uptake is defined as enough uptake that a treatment with high-dose radioactive iodine is possible.

Participants with reinduction of radioiodine uptake in the target lesion will be offered a treatment with high-dose radioactive iodine, according to the guidelines for the treatment of thyroid carcinoma. The beneficial effects of this treatment will be measured after 6 months with a computertomography scan and will be described using the RECIST criteria.

All serious adverse events (SAE) occuring during the digoxin treatment will be described.

Radboud University Medical Center

Hematinics

Other Dietary Supplements

Vitamins

Thioctic Acid

Antioxidants

Folic Acid

Vitamin B Complex

Trace Elements

Alpha-lipoic Acid

Folate

Vitamin B9

Patients who will receive 600 mg/day alpha-lipoic acid

Patients who will receive 1,200 mg/day alpha-lipoic acid

alpha-lipoic acid 600 mg/day or 1,200 mg/day 600 mg/day - Three tablets (200mg x 3), one time per day for 3 months 1,200 mg/day - Three tablets (200mg x 3), two times per day for 3 months

alpha-lipoic acids

Radioiodine (I-131) therapy is of proven efficacy for treatment of differentiated thyroid carcinoma (DTC). However, loss of differentiation in recurrent or metastatic DTC which decrease I-131 uptake may decrease the efficacy of I-131 therapy. Therefore, strategies to improve I-131 uptake are mandatory. This study is an open label clinical study to evaluate the effectiveness of alpha-lipoic acid (ALA) for improving I-131 uptake in recurrent or metastatic of DTC with defective I-131 uptake.

Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer

Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma	NCT05507775	Non-Medullary T...	Digoxin tablet	18 Years -	Radboud University Medical Center
Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer	NCT01396733	Thyroid Cancer	alpha-lipoic ac...	20 Years - 75 Years	Asan Medical Center
Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer	NCT01396733	Thyroid Cancer	alpha-lipoic ac...	20 Years - 75 Years	Asan Medical Center
Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma	NCT05507775	Non-Medullary T...	Digoxin tablet	18 Years -	Radboud University Medical Center

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