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



Status:Terminated
Conditions:Breast Cancer, Cancer, Hot Flash
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:9/14/2018
Start Date:March 2006
End Date:November 2008

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A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer

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.

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.

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)
We found this trial at
19
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Washington, District of Columbia 20060
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600 Moye Boulevard
Greenville, North Carolina 27834
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Decatur, Illinois 62526
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Elkin, North Carolina 28621
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Goldsboro, North Carolina 27534
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Hilton Head Island, South Carolina 29926
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Royal Oak, Michigan 48073
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Saint Louis, Missouri 63141
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Saint Louis Park, Minnesota 55416
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South Bend, Indiana 46601
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Spartanburg, South Carolina 29303
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Springfield, Missouri 65804
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