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Completed

NCT Number: NCT03580499

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

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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Key information

Conditions

Hot Flashes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B6

Dietary Supplement

Given PO

Other names: 8059-24-3, VIT B6, Vitamin B-6, Vitamin B 6

Questionnaire Administration

Other

Ancillary studies

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)

    Time frame: 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 outcomes

  1. Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2018
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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