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

This study has been terminated.
(Stopped due to concerns about interaction between St. John's wort and Tamoxifen.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00110136
First received: May 3, 2005
Last updated: December 17, 2014
Last verified: December 2014
  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
Drug: St. John's Wort
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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:


Further study details as provided by Wake Forest NCORP Research Base:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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) ] [ Designated as safety issue: Yes ]
    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.

  • Effect of St. John's Wort on Quality of Life (MCS) [ Time Frame: Baseline and four weeks ] [ Designated as safety issue: No ]

    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.


  • Effect of St. John's Wort on Quality of Life (PCS) [ Time Frame: Baseline and four weeks ] [ Designated as safety issue: No ]

    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.


  • Mood is Measured by the POMS Short Form. [ Time Frame: Baseline and four weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 9
Study Start Date: March 2006
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: St. John's Wort

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
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
Hugh Chatham Memorial Hospital
Elkin, North Carolina, United States, 28621
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
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
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, United States, 29925
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Wake Forest NCORP Research Base
Investigators
Study Chair: Michelle Naughton, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier: NCT00110136     History of Changes
Other Study ID Numbers: CCCWFU 98301, U10CA081851
Study First Received: May 3, 2005
Results First Received: September 4, 2014
Last Updated: December 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest NCORP Research Base:
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:
Breast Neoplasms
Hot Flashes
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2015