Philadelphia, Pennsylvania 19107


Purpose:

This pilot phase II trial studies how well vitamin B6 works in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy. A nutritional supplement such as vitamin B6 may help improve hot flashes caused by antiandrogen therapy in participants with prostate cancer.


Study summary:

PRIMARY OBJECTIVES: I. To evaluate the effect of Vitamin B6 in improves the frequency or severity of hot flashes in prostate cancer patients receiving antiandrogen therapy (androgen deprivation therapy [ADT]).


Criteria:

Inclusion Criteria: - Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least 13 weeks after enrollment. Patient may have been started on ADT at any past time point because patients experience hot flashes throughout ADT treatment - Subjects are experiencing bothersome hot flashes per the study questionnaires - Subjects are capable of giving informed consent. - Willing to comply with all study procedures and be available for the duration of the study - Able to obtain and take an acceptable form of vitamin B6 Exclusion Criteria: - Subjects without a diagnosis of prostate cancer - Subjects already receiving other treatment for hot flashes - Subjects taking selective serotonin reuptake inhibitors (SSRIs) - Subjects are currently taking vitamin supplementation which includes vitamin B6 at doses > 10 mg


NCT ID:

NCT03580499


Primary Contact:

Principal Investigator
Mark Hurwitz, MD
Sidney Kimmel Cancer Center at Thomas Jefferson University

Anne Calvaresi, MSN
Phone: 215-955-1000
Email: anne.calvaresi@jefferson.edu


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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