Hypericum Perforatum (St. John's Wort) in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer - Full Text View

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00110136

Purpose

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 Hot Flashes	Dietary Supplement: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Primary Outcome Measures:

Effects of St. John's wort on mild to moderate hot flashes as measured by hot flash diary at baseline to 4 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in hot flash scores and duration by hot flash diary at baseline and weeks 1-6 [ Designated as safety issue: No ]
Toxicity at screening, baseline, week 2, week 4, and week 6 [ Designated as safety issue: Yes ]
Effects of St. John's wort on serum tamoxifen levels at screening, baseline, and weeks 2, 4, and 6 [ Designated as safety issue: No ]
Quality of life by POMS and SF-12 at 2 and 4 weeks relative to baseline and during 2 week post-treatment phase [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	March 2006
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

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

Other

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110136

Locations

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

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Michelle Naughton, PhD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Wake Forest University Comprehensive Cancer Center ( Edward G. Shaw )
Study ID Numbers:	CDR0000385684, CCCWFU-98301
Study First Received:	May 3, 2005
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00110136 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wake Forest University Baptist Medical Center:

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

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplasms by Site
Skin Diseases

Hot Flashes
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010