Ignite Creation Date:
2024-05-05 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00541788
Status:
COMPLETED
Last Update Posted:
2010-09-17
First Post:
2007-10-08
Brief Title:
Evaluation of the Efficacy and Safety of Common Sage in Controlling Hot Flashes in Prostate Cancer Patients Treated by Androgen Deprivation
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Common Sage in Controlling Hot Flashes in Prostate Cancer Patients Treated by Androgen Deprivation
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical phase I study is to measure the efficacy and side effects of Common Sage in the treatment of hot flashes in 10 patients with prostate cancer who receive androgen deprivation AD exclusively or as part of a multimodality treatment for a period of minimum 6 months Concomitant use of a non-steroidal anti-androgen during the first month of the AD is permitted to prevent the flair-up phenomenon However the inclusion of patients in the study will only start at least 2 weeks after the cessation of the anti-androgen This is done to exclude a possible influence of the anti-androgen on the severity and frequency of hot flashes
Once the informed consent is signed the patient receives the study diary to note the daily frequency and severity of hot flashes and their effect on daily quality of life The severity of the hot flashes is measured by the Moyad scoring scale The effect on daily quality of life is measured using the Hot Flash Related Daily Interference Scale HFRDIS The patient will be instructed in detail how to use the diary
After week 1 the patient returns the diary to the responsible physician In return the patient receives the study medication Common Sage product and a diary for the next week week 2 This procedure will be repeated until the end of the observation period 2 months after enrollment in the study The common Sage will be provided in tablets The suggested dose of Common Sage is 3 tablets a day morning - noon - evening
To be sure that the effect of Common Sage is NOT due to an inhibition of the effect of the LHRH analogue the related hormones testosterone FSH LH free testosterone and SHBG will be tested at three fixed moments day of study enrollment 1 month after study enrollment and at the end of the study In order to check the level of hemoglobin and cholesterol every 2 weeks a blood count will be performed It has been shown that LHRH analogues can induce anemia and hypercholesterolemia The investigators want to measure a possible effect of Common Sage on both
There are no known side-effects of the use of Common Sage All symptoms that could be related to the use of Common Sage will be recorded in detail Therefore a clinical examination including blood pressure registration will be performed by the responsible physician on a weekly base
Once the informed consent is signed the patient receives the study diary to note the daily frequency and severity of hot flashes and their effect on daily quality of life The severity of the hot flashes is measured by the Moyad scoring scale The effect on daily quality of life is measured using the Hot Flash Related Daily Interference Scale HFRDIS The patient will be instructed in detail how to use the diary
After week 1 the patient returns the diary to the responsible physician In return the patient receives the study medication Common Sage product and a diary for the next week week 2 This procedure will be repeated until the end of the observation period 2 months after enrollment in the study The common Sage will be provided in tablets The suggested dose of Common Sage is 3 tablets a day morning - noon - evening
To be sure that the effect of Common Sage is NOT due to an inhibition of the effect of the LHRH analogue the related hormones testosterone FSH LH free testosterone and SHBG will be tested at three fixed moments day of study enrollment 1 month after study enrollment and at the end of the study In order to check the level of hemoglobin and cholesterol every 2 weeks a blood count will be performed It has been shown that LHRH analogues can induce anemia and hypercholesterolemia The investigators want to measure a possible effect of Common Sage on both
There are no known side-effects of the use of Common Sage All symptoms that could be related to the use of Common Sage will be recorded in detail Therefore a clinical examination including blood pressure registration will be performed by the responsible physician on a weekly base
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None