Breast CancerPhase 2NCT00110136
St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
A Phase 2 study testing St. John's Wort in people with Breast Cancer and Hot Flashes, run by Wake Forest University Health Sciences at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hot Flashes
- What is being tested?
- St. John's Wort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 19 sitesUnited States
- Study dates
- 16 Mar 2006to 1 Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Post-menopausal (i.e., no menstrual periods ≥ 12 months or surgical menopause)
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- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin < 2 mg/dL
- SGOT ≤ 2 times normal
- Renal
- Not specified
Who cannot join
- 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
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- 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)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, 27216
CCOP - Central Illinois
Decatur, Illinois, 62526
Hugh Chatham Memorial Hospital
Elkin, North Carolina, 28621
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, 27835-6028
CCOP - Greenville
Greenville, South Carolina, 29615
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, 29925
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, 19713
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Cancer Research for the Ozarks
Springfield, Missouri, 65804
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Hot Flashes
- Being tested
- St. John's Wort
- 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
- Medical subject headings
- Breast Neoplasms, Hot Flashes, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. John's WortDrug
St. John's Wort 300mg tablet three times per day
| Study group | Role | What they receive |
|---|---|---|
| St. John's Wort | Experimental | Patient given one 300mg St. John's Wort tablet three times per day Receives: Drug: St. John's Wort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort
Measured: Baseline and four weeks
Secondary outcomes (5)
Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks
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.
Measured: Baseline and four weeks
Estimation of Toxicities While on St. John's Wort
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.
Measured: Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)
Effect of St. John's Wort on Quality of Life (MCS)
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.
Measured: Baseline and four weeks
Effect of St. John's Wort on Quality of Life (PCS)
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.
Measured: Baseline and four weeks
Mood is Measured by the POMS Short Form.
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.
Measured: Baseline and four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study start16 Mar 2006
- Primary completion1 Apr 2008
- Study completion1 Apr 2008
Why it stopped: Stopped due to concerns about interaction between St. John's wort and Tamoxifen.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michelle Naughton, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110136
- Sponsor's protocol ID
- REBACCCWFU 98301
- Other IDs
- U10CA081851
- Status last verified
- Sep 2021
- First submitted
- 3 May 2005
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00110136
- Acronym / sponsor ID
- REBACCCWFU 98301
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to concerns about interaction between St. John's wort and Tamoxifen.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Mar 2006 (actual)
- Primary completion
- 1 Apr 2008 (actual)
- Study completion
- 1 Apr 2008 (actual)
- First posted
- 4 May 2005 (estimated)
- Results
- Posted 29 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| St. John's Wort | Experimental | Drug: St. John's WortPatient given one 300mg St. John's Wort tablet three times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age
- 18 and over
- Sex
- Female
- Menopausal status
Key exclusion criteria (42 listed)
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of intolerance to St. John's wort
- Biologic therapy
- Not specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| St. John's WortSt. John's Wort 300mg tablet three times per day | Drug | St. John's Wort |
Primary outcome
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
Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort
5 secondary outcomes
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
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)
Effect of St. John's Wort on Quality of Life (MCS)
Time frame: Baseline and four weeks
Effect of St. John's Wort on Quality of Life (PCS)
Time frame: Baseline and four weeks
Mood is Measured by the POMS Short Form.
Time frame: Baseline and four weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Naughton, PhD study chair
Wake Forest University Health Sciences
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing St. John's Wort in people with Breast Cancer and Hot Flashes, run by Wake Forest University Health Sciences at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.