Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199485
• Other study ID #: S-01-007
• Secondary ID: 08217
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 25, 2008
• Start date: October 2002
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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 are similar to those experienced by women during menopause. A traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.

Recently, the awareness and use of herbal remedies and over-the-counter preparations for a number of different conditions have increased dramatically. This trial was, therefore, designed to determine if Dong Quai significantly reduces the incidence and severity of hot flashes in men following androgen deprivation therapy for prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Angelica Sinensis
Angelica Sinensis / placebo

Locations

Country	Name	City	State
Canada	Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	St. Joseph's Health Care London

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess bone loss in men with prostate cancer being treated with LHRH		at each of 3 follow up visits	No