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

This study has been completed.
Sponsor:
Collaborator:
Farmafyt
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00541788
First received: October 8, 2007
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

The purpose of this clinical phase I study is to measure the efficacy and side effects of Common Sage in the treatment of hot flashes in 10 patients with prostate cancer who receive androgen deprivation (AD) (exclusively or as part of a multimodality treatment) for a period of minimum 6 months. Concomitant use of a non-steroidal anti-androgen during the first month of the AD is permitted to prevent the flair-up phenomenon. However, the inclusion of patients in the study will only start at least 2 weeks after the cessation of the anti-androgen. This is done to exclude a possible influence of the anti-androgen on the severity and frequency of hot flashes.

Once the informed consent is signed, the patient receives the study diary to note the daily frequency and severity of hot flashes and their effect on daily quality of life. The severity of the hot flashes is measured by the Moyad scoring scale. The effect on daily quality of life is measured using the Hot Flash Related Daily Interference Scale (HFRDIS). The patient will be instructed in detail how to use the diary.

After week 1, the patient returns the diary to the responsible physician. In return the patient receives the study medication (Common Sage, product) and a diary for the next week (=week 2). This procedure will be repeated until the end of the observation period (2 months after enrollment in the study). The common Sage will be provided in tablets. The suggested dose of Common Sage is 3 tablets a day (morning - noon - evening).

To be sure that the effect of Common Sage is NOT due to an inhibition of the effect of the LHRH analogue, the related hormones (testosterone, FSH, LH, free testosterone and SHBG) will be tested at three fixed moments: day of study enrollment, 1 month after study enrollment and at the end of the study. In order to check the level of hemoglobin and cholesterol, every 2 weeks a blood count will be performed. It has been shown that LHRH analogues can induce anemia and hypercholesterolemia. The investigators want to measure a possible effect of Common Sage on both.

There are no known side-effects of the use of Common Sage. All symptoms that could be related to the use of Common Sage will be recorded in detail. Therefore, a clinical examination including blood pressure registration will be performed by the responsible physician on a weekly base.


Condition Intervention Phase
Prostate Cancer
Other: Administration of Common Sage
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Common Sage in Controlling Hot Flashes in Prostate Cancer Patients Treated by Androgen Deprivation

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Scoring of virtual side effects. [ Time Frame: 2 months after enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of QOL following HFRDIS. [ Time Frame: 2 months after enrollment ] [ Designated as safety issue: No ]
  • Registration of virtual side effects. [ Time Frame: 2 months after enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: October 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Administration of Common Sage
Other: Administration of Common Sage
Administration of Common Sage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541788

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Farmafyt
Investigators
Principal Investigator: Gert De Meerleer, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Gert De Meerleer, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00541788     History of Changes
Other Study ID Numbers: 2007/285
Study First Received: October 8, 2007
Last Updated: September 16, 2010
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014