Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
St. Joseph's Health Care London
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00199485
First received: September 13, 2005
Last updated: July 25, 2008
Last verified: July 2008
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Hassan Razvi, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00199485     History of Changes
Other Study ID Numbers: S-01-007, 08217
Study First Received: September 13, 2005
Last Updated: July 25, 2008
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014