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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status

Completed

Conditions

Prostate Carcinoma

Hot Flashes

Treatments

Dietary Supplement: Vitamin B6

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

Identifiers

NCT03580499

18D.273

Details and patient eligibility

About

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.

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]).

OUTLINE:

Participants receive vitamin B6 orally (PO) daily for 12 weeks.

Enrollment

43 patients

Sex

Male

Volunteers

No Healthy Volunteers

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