Proliferative Thyroid Disease Clinical Trial
Official title:
Diindolymethane: Anti-proliferation Agent in Thyroid Disease—Non-surgical Protocol
Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables
(such as cabbage, cauliflower, broccoli, & Brussels sprouts) has been studied extensively in
recent years for its anti-cancer effects. DIM has been shown to exert control over cancer
cell growth in breast, uterine, cervical, ovarian, and colon cancer.
To date no human study has been published regarding the bioavailability of DIM in thyroid
tissue or its effects in proliferative thyroid disease. Our previous study attempted to
elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative
thyroid disease and ascertain its uptake in thyroid tissue. DIM has been shown to
concentrate in the thyroid gland. Furthermore, thyroid volumes have been seen to decrease
subjectively.
This study would continue our attempt to elucidate DIM's promotion of anti-proliferative
estrogen metabolites in proliferative thyroid disease.
| Status | Terminated |
| Enrollment | 7 |
| Est. completion date | September 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes. Exclusion Criteria: - Patients who are pregnant, attempting to conceive, or lactating will be excluded due to possible deleterious effects of treatment on fetus/infant. Patients taking oral contraceptives, estrogen therapy, tamoxifin or those with a history of breast cancer will be excluded. Patients with liver disease and those taking statins for hypercholesterolemia will also be excluded to decrease the potential for possible liver toxicity. Any patient with elevated liver enzymes on pretreatment blood screening will be excluded from study participation. Patients with serious systemic diseases such as renal failure, diabetes, blood dyscrasia, coagulopathy, and non-optimized cardiopulmonary disease will be excluded due to the possibility of confounding blood tests screening for toxicity. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | The New York Eye & Ear Infirmary | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| The New York Eye & Ear Infirmary |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evidence of objective and quantifiable changes in thyroid size as a resalt of the oral administration of DIM, confirmed by pre- and post- DIM treatment ultrasounds | after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped | No | |
| Secondary | Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis | after 30 days of DIM consumption | No |