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CompletedNCT00199485Updated Jul 29, 2008

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

A Phase 4 interventional study of Angelica Sinensis in Prostate Cancer, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to male participants. Per ClinicalTrials.gov, last updated 2008-07-29.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Randomized
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

Keywords

  • prostate cancer
  • Luteinizing Hormone Releasing Hormone
  • LHRH
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 44 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    1

    Angelica Sinensis

    Drug: Angelica Sinensis

  • Placebo comparator
    2

    placebo

    Drug: Angelica Sinensis

Interventions

  • DrugAngelica Sinensis

    Angelica Sinensis / placebo

06

What researchers measure

Primary outcomes

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

    Time frame: at each of 3 follow up visits

07

Study locations

1 site
  • Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
    London, Ontario N6A 4V2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00199485
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Collaborators
St. Joseph's Health Care London
First posted
Sep 20, 2005
Start date
Oct 2002
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jul 29, 2008

Study contacts

Hassan Razvi, MD, FRCSC
principal investigator · Urology, St. Joseph's Hospital, University of Western Ontario

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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