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A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Hot Flashes

Thank you

Trial Information

A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of 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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

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

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Michelle Naughton, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CCCWFU 98301

NCT ID:

NCT00110136

Start Date:

March 2006

Completion Date:

November 2008

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • 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
  • Breast Neoplasms
  • Hot Flashes

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - Central IllinoisSpringfield, Illinois  62526
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Alamance Cancer Center at Alamance Regional Medical CenterBurlington, North Carolina  27216
Hugh Chatham Memorial HospitalElkin, North Carolina  28621
Helen F. Graham Cancer Center at Christiana HospitalNewark, Delaware  19718
South Carolina Cancer SpecialistsHilton Head Island, South Carolina  29925