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