Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT00060320
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* History of breast cancer OR concern about taking hormones because of fear of breast cancer
* No current active disease
* No current evidence of malignant disease
* Bothersome hot flashes
* Patient-reported occurrence at least 14 times per week and of sufficient severity to make the patient desire therapeutic intervention
* Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to complete questionnaires alone or with assistance
PRIOR CONCURRENT THERAPY:
Chemotherapy
* More than 4 weeks since prior antineoplastic chemotherapy
* No concurrent antineoplastic chemotherapy during the double-blind portion of the study
Endocrine therapy
* More than 4 weeks since prior androgens, estrogens, or progestational agents
* More than 2 weeks since prior dehydroepiandrosterone (DHEA) for hot flashes
* No concurrent androgens, estrogens, or progestational agents during the double-blind portion of the study
* No concurrent DHEA for hot flashes
* Concurrent tamoxifen, raloxifene, or an aromatase inhibitor is allowed provided the patient started the drug at least 4 weeks prior to study entry and plans to continue the drug throughout the double-blind portion of the study Other
* More than 2 weeks since prior antidepressants
* More than 2 weeks since other prior agents for treating hot flashes (e.g., clonidine or Bellergal-s)
* No prior black cohosh
* No concurrent antidepressants during the double-blind portion of the study
* No other concurrent agents for treating hot flashes (e.g., clonidine or Bellergal-s)
* Concurrent vitamin E and/or soy allowed provided patient is on a stable dose for at least 1 month prior to study entry and plans to continue the same dose throughout study duration
* No concurrent oral herbal therapies or therapeutic herbal teas or tinctures except beverage teas (e.g., chamomile, ginger, peppermint, lemongrass, and fruit-based tea)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00060320
Study Brief:
Protocol Section:
NCT00060320