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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2024-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hot Flashes Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (vitamin B6)

Participants receive vitamin B6 PO daily for 12 weeks.

Group Type EXPERIMENTAL

Vitamin B6

Intervention Type DIETARY_SUPPLEMENT

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Vitamin B6

Given PO

Intervention Type DIETARY_SUPPLEMENT

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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8059-24-3 VIT B6 Vitamin B-6 Vitamin B 6

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No