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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Angelica Sinensis
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, Luteinizing Hormone Releasing Hormone, LHRH

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Angelica Sinensis

placebo

Outcomes

Primary Outcome Measures

assess bone loss in men with prostate cancer being treated with LHRH

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
July 25, 2008
Sponsor
Lawson Health Research Institute
Collaborators
St. Joseph's Health Care London
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1. Study Identification

Unique Protocol Identification Number
NCT00199485
Brief Title
Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer
Official Title
Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute
Collaborators
St. Joseph's Health Care London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, Luteinizing Hormone Releasing Hormone, LHRH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Angelica Sinensis
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Angelica Sinensis
Intervention Description
Angelica Sinensis / placebo
Primary Outcome Measure Information:
Title
assess bone loss in men with prostate cancer being treated with LHRH
Time Frame
at each of 3 follow up visits

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Razvi, MD, FRCSC
Organizational Affiliation
Urology, St. Joseph's Hospital, University of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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