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Evaluation of the Efficacy and Safety of Common Sage in Controlling Hot Flashes in Prostate Cancer Patients Treated by Androgen Deprivation


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Evaluation of the Efficacy and Safety of Common Sage in Controlling Hot Flashes in Prostate Cancer Patients Treated by Androgen Deprivation


Inclusion Criteria:



- Prostate cancer patients treated with androgen deprivation and experiencing hot
flashes.

- Karnofsky performance status ≥70%

- Age ≥18 years

- Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

- Other therapy for hot flashes

- Mental condition rendering the patient unable to understand the nature, scope, and
possible consequences of the study

- Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to
complete the diary, inability to return for follow-up visits, and unlikely to
complete the study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Scoring of virtual side effects.

Outcome Time Frame:

2 months after enrollment

Safety Issue:

Yes

Principal Investigator

Gert De Meerleer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Institutional Review Board

Study ID:

2007/285

NCT ID:

NCT00541788

Start Date:

October 2007

Completion Date:

June 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Hot Flashes

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