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

NCT03580499 | Completed DMC

• 2 other identifiers: 18D.273JT 12134
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes; Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Supportive Care (vitamin B6)

EXPERIMENTAL

Participants receive vitamin B6 PO daily for 12 weeks.

Dietary Supplement: Vitamin B6; Other: Questionnaire Administration

Interventions

Vitamin B6 DIETARY_SUPPLEMENT

Given PO

Also known as: 8059-24-3, VIT B6, Vitamin B-6, Vitamin B 6

Supportive Care (vitamin B6)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (vitamin B6)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Hot Flashes; Prostatic Neoplasms

Interventions

Vitamin B 6

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Costas Lallas, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 9, 2018
• Study Start: September 13, 2018
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)