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

NCT00199485 | Completed Phase 4

• 2 other identifiers: S-01-00708217
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; Luteinizing Hormone Releasing Hormone; LHRH

Outcome Measures

Primary Outcomes (1)

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

  at each of 3 follow up visits

Study Arms (2)

1

EXPERIMENTAL

Angelica Sinensis

Drug: Angelica Sinensis

2

PLACEBO COMPARATOR

placebo

Drug: Angelica Sinensis

Interventions

Angelica Sinensis DRUG

Angelica Sinensis / placebo

1; 2

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• St. Joseph's Health Care London: collaborator

Study Sites (1)

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

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

angelicae sinensis extract

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hassan Razvi, MD, FRCSC

  Urology, St. Joseph's Hospital, University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2002
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 29, 2008

Record last verified: 2008-07

Locations

CA (1)