St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer, Hot Flashes

In brief

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.

Key facts

Study ID

NCT00110136

Run by

Wake Forest University Health Sciences

People needed

9

Starts

2006-03-16

Expected to finish

2008-04-01

Last updated by the study team

2021-09-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Post-menopausal (i.e., no menstrual periods ≥ 12 months or surgical menopause)
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Not specified
• Hepatic
• Bilirubin < 2 mg/dL
• SGOT ≤ 2 times normal
• Renal
• Not specified

You may not qualify if…

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No history of intolerance to St. John's wort
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• No concurrent cytotoxic chemotherapy
• Endocrine therapy
• No concurrent selective estrogen-receptor modulators or aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) allowed
• Concurrent tamoxifen allowed
• No concurrent estrogen, progestational agents, or androgens for the alleviation of hot flashes
• No concurrent corticosteroids
• Radiotherapy
• Not specified
• Surgery
• Not specified
• Other
• More than 14 days since prior Hypericum perforatum (St. John's wort), monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (e.g., sertraline, paroxetine, or fluoxetine) or selective norepinephrine reuptake inhibitors (e.g., venlafaxine)
• No concurrent use of any of the following:
• Antidepressants
• Theophylline
• Warfarin, unless for central line prophylaxis
• Protease inhibitors for AIDS
• Digoxin

Where it is running

• Helen F. Graham Cancer Center at Christiana Hospital — Newark, Delaware, United States
• MBCCOP - Howard University Cancer Center — Washington D.C., District of Columbia, United States
• University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States
• CCOP - Central Illinois — Decatur, Illinois, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• Feist-Weiller Cancer Center at Louisiana State University Health Sciences — Shreveport, Louisiana, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• CCOP - Beaumont — Royal Oak, Michigan, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• Cancer Research for the Ozarks — Springfield, Missouri, United States
• CCOP - St. Louis-Cape Girardeau — St Louis, Missouri, United States
• Alamance Cancer Center at Alamance Regional Medical Center — Burlington, North Carolina, United States
• Hugh Chatham Memorial Hospital — Elkin, North Carolina, United States
• CCOP - Southeast Cancer Control Consortium — Goldsboro, North Carolina, United States
• Leo W. Jenkins Cancer Center at ECU Medical School — Greenville, North Carolina, United States
• Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
• CCOP - Greenville — Greenville, South Carolina, United States
• South Carolina Cancer Specialists — Hilton Head Island, South Carolina, United States
• CCOP - Upstate Carolina — Spartanburg, South Carolina, United States

Full record on ClinicalTrials.gov

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