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

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

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.

Study Overview

• Status: Completed
• Conditions: Hot Flashes; Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Dietary supplement: Vitamin B6

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (vitamin B6); Participants receive vitamin B6 PO daily for 12 weeks.	Other: Questionnaire Administration; Ancillary studies; Dietary supplement: Vitamin B6; Given PO; Other Names: 8059-24-3; VIT B6; Vitamin B-6; Vitamin B 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Costas Lallas, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Neoplasms; Hot Flashes; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Picolines; Vitamin B 6
• Other Study ID Numbers: 18D.273; JT 12134 (Other Identifier: JeffTrial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No