Clinical trial · Interventional
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
NCT00110136CI-TRIAL-00054160terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stopped due to concerns about interaction between St. John's wort and Tamoxifen.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| St. John's Wort | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- St. John's Wort
- description
- Patient given one 300mg St. John's Wort tablet three times per day
- interventionNames
- Drug: St. John's Wort
Primary outcomes (1)
- 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
- description
- Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort
Secondary outcomes (5)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.