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

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03580499

Collaborator

(none)

Enrollment

Location

Arm

40.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes Prostate Carcinoma	Dietary Supplement: Vitamin B6	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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]).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients

Actual Study Start Date :

Sep 13, 2018

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supportive Care (vitamin B6) Participants receive vitamin B6 PO daily for 12 weeks.	Dietary Supplement: Vitamin B6 Given PO Other Names: 8059-24-3 VIT B6 Vitamin B-6 Vitamin B 6

Arm

Intervention/Treatment

Experimental: Supportive Care (vitamin B6)

Participants receive vitamin B6 PO daily for 12 weeks.

Dietary Supplement: Vitamin B6

Given PO

Other Names:

8059-24-3

VIT B6

Vitamin B-6

Vitamin B 6

Outcome Measures

Primary Outcome Measures

Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe) [Baseline to 8 weeks]
For the primary analysis, the difference in the median response to the 10-point hot flash scale between 8-week post-treatment and pre-treatment responses will be computed with the corresponding 95% percent confidence interval. The primary null hypothesis will be tested using a two-sided Wilcoxon Signed-Rank Test with alpha=0.05.

Secondary Outcome Measures

Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe) [Baseline to 12 weeks]
The same approach will be used for the secondary analysis of 12-week post-treatment responses in comparison to the pre-treatment responses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts 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