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Vitamin B6 may cool hot flashes for men on prostate cancer therapy

NCT ID NCT03580499

Symptom relief Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether vitamin B6 supplements can reduce hot flashes in 43 men with prostate cancer who were receiving hormone therapy (ADT). Hot flashes are a common side effect of this treatment. The study measured how bothersome hot flashes were before and after 8 and 12 weeks of vitamin B6, using a simple 1-to-10 scale.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

43 people

The number who actually took part.

Started

Sep 2018

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hot Flashes prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hot flashes Prostate carcinoma

Contacts and locations

Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.