Status:
COMPLETED
Brown Seaweed as a Breast Cancer Preventive
Lead Sponsor:
University of South Carolina
Collaborating Sponsors:
Susan G. Komen Breast Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Japanese postmenopausal women in Japan have about one ninth the rate of American postmenopausal women. Rates of breast cancer double even after just ten years among Japanese women who migrate to the U...
Detailed Description
33 healthy postmenopausal women were randomized to 6 wk seaweed then 1 wk seaweed plus soy or 6 wk placebo then 1 wk placebo plus soy. Blood and urine samples were collected at the end of each treatme...
Eligibility Criteria
Inclusion
- Postmenopausal (self-reported cessation of menstruation 1 y prior to enrollment)
- If breast cancer survivor, all therapy completed at least 6 months prior to enrollment
- Agreed to eat their normal diet, avoiding seaweeds and phytoestrogen-rich foods,
- Restricting alcoholic intake to #2 drinks (24 g alcohol)/wk -Continuing habitual intake of vitamins, supplements, and medications during the study. -
Exclusion
- No allergies to seaweed, soy, shellfish, or iodine
- No current use of tobacco;
- No thyroid dysfunction or treatment within the previous 5 y;
- Negative thyroid peroxidase antibodies as determined by screening;
- No hormone replacement therapy or for breast cancer survivors, no chemotherapy or radiation treatments within the preceding 6 mo
- No history of cancer (other than breast cancer)
- No current gastrointestinal disorders or diabetes; omnivorous eating habits, including meat and dairy products at least twice/wk
- No oral antibiotics, iodine containing medications, or corticosteroids treatment within the previous 3 mo.
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1999
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01204957
Start Date
October 1 1998
End Date
March 1 1999
Last Update
April 6 2015
Active Locations (1)
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1
University of Massachusetts
Worcester, Massachusetts, United States, 01655