A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer
18 Years
N/A
Female
Breast Cancer, Hot Flashes
Trial Information
A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer
OBJECTIVES:
Primary
- Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot
flashes, in terms of hot flash frequency, score, and duration and disruption of daily
activities caused by hot flashes, in postmenopausal women with non-metastatic breast
cancer.
- Determine hot flash changes over 4 weeks in patients treated with this drug.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine the effect of Hypericum perforatum (St. John's wort) on serum tamoxifen
levels in women receiving tamoxifen therapy.
- Determine the effect of Hypericum perforatum (St. John's wort) on general
health-related quality of life and mood at 2 and 4 weeks relative to baseline, and
during the 2 week post-treatment phase in these patients.
- To evaluate changes in average weekly hot flush scores and duration over course of
study.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Noninvasive ductal carcinoma in situ
- Localized breast cancer
- Stage 0-IIIB disease
- Locally recurrent breast cancer that is post-treatment AND disease-free for ≥ 2
years
- Experiencing ≥ 3 hot flashes per day (≥ 21 per week), defined by sweating, flushing,
sensation of warmth, night sweats, and/or rapid heart beat of sufficient severity
that the patient desires therapeutic intervention
- Normal mammogram within the past 10 months
- Hormone receptor status:
- Not specified
INCLUSION CRITERIA:
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
EXCLUSION CRITERIA:
- 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
- Cyclosporine
- Benzodiazepines (e.g., diazepam or alprazolam)
- Calcium-channel blockers (e.g., diltiazem or nifedipine)
- Coenzyme A reductase inhibitors for serum cholesterol reduction
- Macrolide antibiotics (e.g., azithromycin, erythromycin, or clarithromycin)
- Griseofulvin
- Phenobarbital
- Phenytoin
- Rifampin
- Rifabutin
- Grapefruit juice
- Other naturopathic or herbal products
- Ketoconazole
- Fluconazole
- Itraconazole
- Rifabutin
- No other concurrent medications for the alleviation of hot flashes (e.g., clonidine
or bellamine)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Effects of St. John's wort on mild to moderate hot flashes as measured by hot flash diary at baseline to 4 weeks
Outcome Time Frame:
One year
Safety Issue:
No
Principal Investigator
Michelle Naughton, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Food and Drug Administration
Study ID:
CCCWFU 98301
NCT ID:
NCT00110136
Start Date:
March 2006
Completion Date:
November 2008
Related Keywords:
- Breast Cancer
- Hot Flashes
- 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
- Breast Neoplasms
- Hot Flashes
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
| Alamance Cancer Center at Alamance Regional Medical Center | Burlington, North Carolina 27216 |
| Hugh Chatham Memorial Hospital | Elkin, North Carolina 28621 |
| Helen F. Graham Cancer Center at Christiana Hospital | Newark, Delaware 19718 |
| South Carolina Cancer Specialists | Hilton Head Island, South Carolina 29925 |
