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

Primary Purpose

Breast Cancer, Hot Flashes

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
St. John's Wort
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Helen F. Graham Cancer Center at Christiana Hospital
  • MBCCOP - Howard University Cancer Center
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • CCOP - Central Illinois
  • CCOP - Northern Indiana CR Consortium
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Beaumont
  • CCOP - Metro-Minnesota
  • CCOP - St. Louis-Cape Girardeau
  • Cancer Research for the Ozarks
  • Alamance Cancer Center at Alamance Regional Medical Center
  • Hugh Chatham Memorial Hospital
  • CCOP - Southeast Cancer Control Consortium
  • Leo W. Jenkins Cancer Center at ECU Medical School
  • Wake Forest University Comprehensive Cancer Center
  • CCOP - Greenville
  • South Carolina Cancer Specialists
  • CCOP - Upstate Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

St. John's Wort

Arm Description

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

Outcomes

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
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
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
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)
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)
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.
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.

Full Information

First Posted
May 3, 2005
Last Updated
September 28, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00110136
Brief Title
St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to concerns about interaction between St. John's wort and Tamoxifen.
Study Start Date
March 16, 2006 (Actual)
Primary Completion Date
April 1, 2008 (Actual)
Study Completion Date
April 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
St. John's Wort
Arm Type
Experimental
Arm Description
Patient given one 300mg St. John's Wort tablet three times per day
Intervention Type
Drug
Intervention Name(s)
St. John's Wort
Intervention Description
St. John's Wort 300mg tablet three times per day
Primary Outcome Measure Information:
Title
Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
Description
Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort
Time Frame
Baseline and four weeks
Secondary Outcome Measure Information:
Title
Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
Description
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.
Time Frame
Baseline and four weeks
Title
Estimation of Toxicities While on St. John's Wort
Description
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.
Time Frame
Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)
Title
Effect of St. John's Wort on Quality of Life (MCS)
Description
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.
Time Frame
Baseline and four weeks
Title
Effect of St. John's Wort on Quality of Life (PCS)
Description
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.
Time Frame
Baseline and four weeks
Title
Mood is Measured by the POMS Short Form.
Description
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.
Time Frame
Baseline and four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Naughton, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Helen F. Graham Cancer Center at Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
MBCCOP - Howard University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Alamance Cancer Center at Alamance Regional Medical Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Hugh Chatham Memorial Hospital
City
Elkin
State/Province
North Carolina
ZIP/Postal Code
28621
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Leo W. Jenkins Cancer Center at ECU Medical School
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835-6028
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
South Carolina Cancer Specialists
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29925
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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