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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00110136
• Other study ID #: REBACCCWFU 98301
• Secondary ID: U10CA081851
• Status: Terminated
• Phase: Phase 2
• Start date: March 16, 2006
• Est. completion date: April 1, 2008

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 1, 2008
• Est. primary completion date: April 1, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hot Flashes

Intervention

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

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Hugh Chatham Memorial Hospital	Elkin	North Carolina
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina
United States	South Carolina Cancer Specialists	Hilton Head Island	South Carolina
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida
United States	Helen F. Graham Cancer Center at Christiana Hospital	Newark	Delaware
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Cancer Research for the Ozarks	Springfield	Missouri
United States	MBCCOP - Howard University Cancer Center	Washington	District of Columbia
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks	Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort	Baseline and four weeks
Secondary	Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks	The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week.; Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days.; Score ranges from 0 to infinity; Lower scores are better.	Baseline and four weeks
Secondary	Estimation of Toxicities While on St. John's Wort	Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.	Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)
Secondary	Effect of St. John's Wort on Quality of Life (MCS)	Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS.; SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.; MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health.; The range is 0 to 100.; Higher scores represent better mental health.	Baseline and four weeks
Secondary	Effect of St. John's Wort on Quality of Life (PCS)	Quality of life was measured by the SF12 (MCS and PCS subscales). Now we'll summarize the PCS.; SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.; PCS is the physical health component of the SF-12. Normal population has a mean of 50 and a SD of 10. Higher scores reflect better physical health.; The range is 0 to 100.; Higher scores represent better mental health.	Baseline and four weeks
Secondary	Mood is Measured by the POMS Short Form.	POMS stands for the Profile of Mood States This is a short version of the POMS (17 questions).; Each question is scored on a 0 to 4 scale. The POMS score is the sum of the responses to the 17 questions. Responses to some questions have been reversed to make higher responses better.; The range is 0 to 68.; Higher scores represent better overall mood.	Baseline and four weeks