Prostate Cancer Clinical Trial

Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy

Summary

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.

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Full Description

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]).

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT03580499

Recruitment Status:

Recruiting

Sponsor:

Sidney Kimmel Cancer Center at Thomas Jefferson University

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There is 1 Location for this study

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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Anne Calvaresi, MSN
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT03580499

Recruitment Status:

Recruiting

Sponsor:


Sidney Kimmel Cancer Center at Thomas Jefferson University

How clear is this clinincal trial information?

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