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

September 28, 2021 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center at Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • MBCCOP - Howard University Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
    • Illinois
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Indiana
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Springfield, Missouri, United States, 65804
        • Cancer Research for the Ozarks
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Alamance Cancer Center at Alamance Regional Medical Center
      • Elkin, North Carolina, United States, 28621
        • Hugh Chatham Memorial Hospital
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
      • Greenville, North Carolina, United States, 27835-6028
        • Leo W. Jenkins Cancer Center at ECU Medical School
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Hilton Head Island, South Carolina, United States, 29925
        • South Carolina Cancer Specialists
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: St. John's Wort
Patient given one 300mg St. John's Wort tablet three times per day
Drug: St. John's Wort
St. John's Wort 300mg tablet three times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
Time Frame: Baseline and four 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
Time Frame: Baseline and four 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
Estimation of Toxicities While on St. John's Wort
Time Frame: Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)
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)
Effect of St. John's Wort on Quality of Life (MCS)
Time Frame: Baseline and four weeks

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
Effect of St. John's Wort on Quality of Life (PCS)
Time Frame: Baseline and four weeks

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
Mood is Measured by the POMS Short Form.
Time Frame: Baseline and four weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michelle Naughton, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 3, 2005

First Submitted That Met QC Criteria

May 3, 2005

First Posted (Estimate)

May 4, 2005

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBACCCWFU 98301
  • U10CA081851 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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