Clinical trial NCT00110136: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-05-04
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
timeFrame: Baseline and four weeks
Secondary outcomes:
measure: Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
timeFrame: Baseline and four weeks
measure: Estimation of Toxicities While on St. John's Wort
timeFrame: Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)
measure: Effect of St. John's Wort on Quality of Life (MCS)
timeFrame: Baseline and four weeks
measure: Effect of St. John's Wort on Quality of Life (PCS)
timeFrame: Baseline and four weeks
measure: Mood is Measured by the POMS Short Form.
timeFrame: Baseline and four weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F. Graham Cancer Center at Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: MBCCOP - Howard University Cancer Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Shreveport
country: United States
facility: Feist-Weiller Cancer Center at Louisiana State University Health Sciences
state: Louisiana
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Royal Oak
country: United States
facility: CCOP - Beaumont
state: Michigan
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: CCOP - St. Louis-Cape Girardeau
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks
state: Missouri
city: Burlington
country: United States
facility: Alamance Cancer Center at Alamance Regional Medical Center
state: North Carolina
city: Elkin
country: United States
facility: Hugh Chatham Memorial Hospital
state: North Carolina
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center at ECU Medical School
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Hilton Head Island
country: United States
facility: South Carolina Cancer Specialists
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michelle Naughton, PhD
role: STUDY_CHAIR
References: