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


Phase 4
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at each of 3 follow up visits

Safety Issue:

No

Principal Investigator

Hassan Razvi, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Canada: Health Canada

Study ID:

S-01-007

NCT ID:

NCT00199485

Start Date:

October 2002

Completion Date:

June 2008

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Luteinizing Hormone Releasing Hormone
  • LHRH
  • Prostatic Neoplasms
  • Hot Flashes

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