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

Lawson Health Research Institute

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Angelica Sinensis

Study type

Interventional

Funder types

Other

Identifiers

NCT00199485

S-01-007

08217

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

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.