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	Treatment or Intervention	Phase
Breast Cancer breast cancer in situ Hot Flashes	Drug: Hypericum perforatum  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: complications of therapy assessment/management  Procedure: herbal medicine / botanical therapy  Procedure: hot flashes attenuation  Procedure: menopausal symptoms attenuation  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES:

• 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 women with non-metastatic breast cancer.
• Determine hot flash changes over 3 months in patients treated with this drug.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral Hypericum perforatum (St. John's wort) once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Patients complete a daily diary of the frequency, severity, and duration of their hot flashes beginning 1 week before the administration of the study drug and continuing for 3 months during study treatment.

PROJECTED ACCRUAL: Approximately 34-92 patients will be accrued for this study within 12 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 ≥ 1 hot flash per day (≥ 7 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
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin < 2 mg/dL
• SGOT ≤ 2 times normal

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• 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

• Concurrent selective estrogen-receptor modulators (e.g., tamoxifen) or aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) allowed provided treatment continues for the duration of the study
• 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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00110136

Study chairs or principal investigators

Gretchen Kimmick, MD, MS,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000385684; CCCWFU-98301; NCT00110136
Record last reviewed:  April 2005
Last Updated:  May 12, 2005
Record first received:  May 3, 2005
ClinicalTrials.gov Identifier:  NCT00110136
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17