Diindolylmethane in Treating Patients With Breast Cancer
Completed · Not applicable · Has a placebo group
Conditions studied: Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
In brief
This phase II/III trial studies how well diindolylmethane (DIM) works and compares it to placebo in treating patients with breast cancer. DIM may slow the growth of tumor cells and be an effective treatment for breast cancer.
Key facts
- Study ID
- NCT01391689
- Run by
- University of Arizona
- People needed
- 144
- Starts
- 2011-02-01
- Expected to finish
- 2016-07-31
- Last updated by the study team
- 2017-11-06
Who can join
Age: 19 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Prescribed TAM as adjuvant therapy for early stage (0, I, II, IIIa) breast cancer or as chemoprevention in women at high risk for breast cancer
- New or planned prescription of TAM therapy; ineligible for randomization until on TAM for > 3 months with the expectation to continue use for > 18 months
- Mammogram with Breast Imaging Reporting and Data System (BIRADS) score of >= 2; (equivalent to the following and similar breast density descriptive terms found in mammogram reports: 2 = scattered fibroglandular elements/densities; 3 = heterogeneously dense tissue; 4 = extremely dense tissue)
- No use of soy-based dietary supplements or willingness to discontinue use, complete a 4-week wash-out period, prior to randomization, and refrain from use during trial period
- If pre-menopausal, non-pregnant (confirmed with urinary pregnancy test); practicing birth control or s/p oophorectomy
- Able to complete study run-in activities, including taking study-provided placebo pill twice daily (AM \& PM) and recording pill intake and any symptoms experienced on a study calendar, with a compliance rate of at least 80%
- Normal blood chemistry test that includes sodium and specific kidney and liver function tests (creatinine, alanine amino transferase-ALT, aspartate amino transferase-AST) within 30 days of study enrollment; (Informed Consent Form signed)
- No history of hyponatremia
Where it is running
- Arizona Cancer Center — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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