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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

London, Ontario, N6A 4V2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Angelica sinensis

Drug

Angelica Sinensis / placebo

Primary outcomes

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

Time frame: at each of 3 follow up visits

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

St. Joseph's Health Care London

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2008
Study completion: 2008
First posted: Sep 20, 2005
Registry last updated: Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed