Status:
COMPLETED
Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
St. Joseph's Health Care London
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE4
Brief Summary
Men undergoing androgen deprivation therapy for prostate cancer may experience significant side effects including symptoms of intense heat, facial flushing, and sweating. These so-called hot flashes a...
Eligibility Criteria
Inclusion
- Prostate cancer treated with some form of androgen deprivation therapy for at least one month. This includes either surgical (bilateral orchidectomy) or medical (LHRH agonist, pure or steroidal antiandrogen or combined) castration;
- Greater than seven vasomotor episodes per week;
- Significantly bothersome symptoms associated with these vasomotor episodes, which produce a desire in the patient to seek treatment to reduce both their incidence and severity;
- Documented informed consent to participate in the trial.
Exclusion
- Enrolment in any other clinical trial or study protocol;
- Presence of pain due to prostate cancer;
- Life expectancy less than three months;
- Any severe concomitant condition that would make it undesirable, in the clinician's opinion, or the subject to participate in the trial or would jeopardize compliance with the trial protocol;
- Concomitant anticoagulation therapy or history of bleeding disorder or blood dyscrasia;
- Known hypersensitivity to Dong Quai.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00199485
Start Date
October 1 2002
End Date
June 1 2008
Last Update
July 29 2008
Active Locations (1)
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1
Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2