Know Cancer

or
forgot password

Diindolymethane: Anti-proliferation Agent in Thyroid Disease—Non-surgical Protocol


Phase 0
18 Years
65 Years
Not Enrolling
Both
Proliferative Thyroid Disease

Thank you

Trial Information

Diindolymethane: Anti-proliferation Agent in Thyroid Disease—Non-surgical Protocol


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Time Frame:

after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped

Safety Issue:

No

Principal Investigator

Stimson P. Schantz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The New York Eye & Ear Infirmary

Authority:

United States: Food and Drug Administration

Study ID:

NYEEI06.33

NCT ID:

NCT01846364

Start Date:

November 2006

Completion Date:

September 2011

Related Keywords:

  • Proliferative Thyroid Disease
  • Thyroid
  • DIM
  • Thyroid Diseases

Name

Location
The New York Eye & Ear Infirmary New York, New York  10003