Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110136
Status:
TERMINATED
Last Update Posted:
2021-09-29
First Post:
2005-05-03
Brief Title:
St Johns Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Study of St Johns Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped due to concerns about interaction between St Johns wort and Tamoxifen
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE St Johns wort may help relieve hot flashes in women with breast cancer
PURPOSE This phase II trial is studying how well St Johns wort works in relieving hot flashes in women with non-metastatic breast cancer
PURPOSE This phase II trial is studying how well St Johns wort works in relieving hot flashes in women with non-metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of Hypericum perforatum St Johns 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 Johns wort on serum tamoxifen levels in women receiving tamoxifen therapy
Determine the effect of Hypericum perforatum St Johns 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 Johns 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
Primary
Determine the efficacy of Hypericum perforatum St Johns 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 Johns wort on serum tamoxifen levels in women receiving tamoxifen therapy
Determine the effect of Hypericum perforatum St Johns 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 Johns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |