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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00110136
First received: May 3, 2005
Last updated: April 1, 2013
Last verified: April 2013

May 3, 2005
April 1, 2013
March 2006
April 2008   (final data collection date for primary outcome measure)
Effects of St. John's wort on mild to moderate hot flashes as measured by hot flash diary at baseline to 4 weeks [ Time Frame: One year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00110136 on ClinicalTrials.gov Archive Site
  • Changes in hot flash scores and duration by hot flash diary at baseline and weeks 1-6 [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Toxicity at screening, baseline, week 2, week 4, and week 6 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Effects of St. John's wort on serum tamoxifen levels at screening, baseline, and weeks 2, 4, and 6 [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Quality of life by POMS and SF-12 at 2 and 4 weeks relative to baseline and during 2 week post-treatment phase [ Time Frame: One year ] [ Designated as safety issue: No ]
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.
 
Completed
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 Cancer Center CCOP Research Base
Wake Forest Cancer Center CCOP Research Base
National Cancer Institute (NCI)
Study Chair: Michelle Naughton, PhD Comprehensive Cancer Center of Wake Forest University
Wake Forest Cancer Center CCOP Research Base
April 2013

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