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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199485
First Posted: September 20, 2005
Last Update Posted: July 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Joseph's Health Care London
Information provided by:
Lawson Health Research Institute
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Drug: Angelica Sinensis Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • assess bone loss in men with prostate cancer being treated with LHRH [ Time Frame: at each of 3 follow up visits ]

Estimated Enrollment: 44
Study Start Date: October 2002
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Angelica Sinensis
Drug: Angelica Sinensis
Angelica Sinensis / placebo
Placebo Comparator: 2
placebo
Drug: Angelica Sinensis
Angelica Sinensis / placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199485


Locations
Canada, Ontario
Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
St. Joseph's Health Care London
Investigators
Principal Investigator: Hassan Razvi, MD, FRCSC Urology, St. Joseph's Hospital, University of Western Ontario
  More Information

Responsible Party: Dr. Hassan Razvi, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00199485     History of Changes
Other Study ID Numbers: S-01-007
08217
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Lawson Health Research Institute:
prostate cancer
Luteinizing Hormone Releasing Hormone
LHRH

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms