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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110136 |
RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.
PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition |
Drug: St. John's wort |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer |
Estimated Enrollment: | 39 |
Study Start Date: | March 2006 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral Hypericum perforatum (St. John's wort) three times daily for 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete a daily diary of the frequency, severity, and duration of their hot flashes, and complete quality of life and mood assessments every 2 weeks during study treatment and continuing weekly for 2 weeks after completion of study treatment.
Patients receiving tamoxifen will have blood tests to measure serum tamoxifen levels at baseline, 2, 4, and 6 weeks.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Localized breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent selective estrogen-receptor modulators or aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) allowed
Radiotherapy
Surgery
Other
No concurrent use of any of the following:
United States, Delaware | |
Helen F. Graham Cancer Center at Christiana Hospital | |
Newark, Delaware, United States, 19713 | |
United States, District of Columbia | |
MBCCOP - Howard University Cancer Center | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
CCOP - Central Illinois | |
Decatur, Illinois, United States, 62526 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
United States, Louisiana | |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
Shreveport, Louisiana, United States, 71130-3932 | |
United States, Michigan | |
CCOP - Beaumont | |
Royal Oak, Michigan, United States, 48073-6769 | |
CCOP - Michigan Cancer Research Consortium | |
Ann Arbor, Michigan, United States, 48106 | |
United States, Minnesota | |
CCOP - Metro-Minnesota | |
St. Louis Park, Minnesota, United States, 55416 | |
United States, Missouri | |
Cancer Research for the Ozarks | |
Springfield, Missouri, United States, 65804 | |
CCOP - St. Louis-Cape Girardeau | |
St. Louis, Missouri, United States, 63141 | |
United States, North Carolina | |
Alamance Cancer Center at Alamance Regional Medical Center | |
Burlington, North Carolina, United States, 27216 | |
CCOP - Southeast Cancer Control Consortium | |
Goldsboro, North Carolina, United States, 27534-9479 | |
Hugh Chatham Memorial Hospital | |
Elkin, North Carolina, United States, 28621 | |
Leo W. Jenkins Cancer Center at ECU Medical School | |
Greenville, North Carolina, United States, 27835-6028 | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, South Carolina | |
CCOP - Greenville | |
Greenville, South Carolina, United States, 29615 | |
CCOP - Upstate Carolina | |
Spartanburg, South Carolina, United States, 29303 | |
South Carolina Cancer Specialists | |
Hilton Head Island, South Carolina, United States, 29925 |
Study Chair: | Michelle Naughton, PhD | Wake Forest University |
Study ID Numbers: | CDR0000385684, CCCWFU-98301 |
Study First Received: | May 3, 2005 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00110136 |
Health Authority: | United States: Food and Drug Administration |
recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer breast cancer in situ ductal breast carcinoma in situ hot flashes |
Signs and Symptoms Skin Diseases Carcinoma in Situ Hot Flashes Breast Neoplasms |
Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Breast Diseases Recurrence Carcinoma |
Neoplasms Neoplasms by Site |