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

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03580499
• Other study ID #: 18D.273
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes
• Prostate Carcinoma

Intervention

Dietary Supplement:
• Vitamin B6
Given PO

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)	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.	Baseline to 8 weeks
Secondary	Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)	The same approach will be used for the secondary analysis of 12-week post-treatment responses in comparison to the pre-treatment responses.	Baseline to 12 weeks

External Links

•   Thomas Jefferson University Hospital