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

May 3, 2005
December 17, 2014
March 2006
April 2008   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00110136 on ClinicalTrials.gov Archive Site
  • 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.

Not Provided
Not Provided
Not Provided
 
St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Hot Flashes
Drug: St. John's Wort
St. John's Wort 300mg tablet three times per day
Other Name: St. John's Wort
Experimental: St. John's Wort
Patient given one 300mg St. John's Wort tablet three times per day
Intervention: Drug: St. John's Wort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
November 2008
April 2008   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110136
CCCWFU 98301, U10CA081851
Yes
Wake Forest NCORP Research Base
Wake Forest NCORP Research Base
National Cancer Institute (NCI)
Study Chair: Michelle Naughton, PhD Comprehensive Cancer Center of Wake Forest University
Wake Forest NCORP Research Base
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP