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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Angelica Sinensis


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Angelica Sinensis | Drug: Angelica Sinensis<br>* Angelica Sinensis / placebo<br>|
| Placebo Comparator: 2<br>placebo | Drug: Angelica Sinensis<br>* Angelica Sinensis / placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess bone loss in men with prostate cancer being treated with LHRH |  | at each of 3 follow up visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LHRH, prostate cancer, Luteinizing Hormone Releasing Hormone