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

NCT ID: NCT00110136

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-16
• Study Completion Date: 2008-04-01

Brief Summary

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.

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.

Conditions

Breast Cancer; Hot Flashes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

St. John's Wort

Patient given one 300mg St. John's Wort tablet three times per day

Group Type: EXPERIMENTAL

St. John's Wort

Intervention Type: DRUG

St. John's Wort 300mg tablet three times per day

Interventions

St. John's Wort

St. John's Wort 300mg tablet three times per day

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Naughton, PhD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

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

Countries

United States

Other Identifiers

U10CA081851

Identifier Type: NIH

Identifier Source: secondary_id

View Link

REBACCCWFU 98301

Identifier Type: -

Identifier Source: org_study_id