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Vitamin B6 for Hot Flashes in Prostate Cancer

N/A

Recruiting

Led By Anne Calvaresi, MSN

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least 13 weeks after enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks

Awards & highlights

Study Summary

This trialstudies how vitamin B6 may help reduce hot flashes in prostate cancer patients taking antiandrogen therapy.

Who is the study for?

This trial is for men with prostate cancer who are having bothersome hot flashes due to antiandrogen therapy. They must be on this therapy for at least 13 more weeks, able to consent, follow study rules, and take vitamin B6. Men already treating hot flashes or taking high-dose B6 supplements or SSRIs can't join.Check my eligibility

What is being tested?

The trial is testing if vitamin B6 can reduce hot flashes in men undergoing antiandrogen therapy for prostate cancer. It's a phase II study to see how effective the vitamin is as a nutritional supplement to manage these symptoms.See study design

What are the potential side effects?

Vitamin B6 may cause mild side effects like nausea, headache, drowsiness, or tingling sensations. However, it's generally considered safe when taken as directed in the context of a clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on hormone therapy for prostate cancer and will continue it for at least 13 weeks after joining.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

Side effects data

From 2014 Phase 2 & 3 trial • 13 Patients • NCT01128244

Vasovagal reaction

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin B6 Effects in OC Users

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care (vitamin B6)Experimental Treatment2 Interventions

Participants receive vitamin B6 PO daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin B6

2020

Completed Phase 3

~320

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,868 Total Patients Enrolled

12 Trials studying Prostate Cancer

1,524 Patients Enrolled for Prostate Cancer

Anne Calvaresi, MSNPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Costas Lallas, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Media Library

Vitamin B6 Clinical Trial Eligibility Overview. Trial Name: NCT03580499 — N/A

Prostate Cancer Research Study Groups: Supportive Care (vitamin B6)

Prostate Cancer Clinical Trial 2023: Vitamin B6 Highlights & Side Effects. Trial Name: NCT03580499 — N/A

Vitamin B6 2023 Treatment Timeline for Medical Study. Trial Name: NCT03580499 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patient slots available for this trial?

"This clinical trial is actively recruiting individuals according to information published on clinicaltrials.gov. The study was initially posted in September 2018 and its latest update occurred in November 2022."

Answered by AI

How many subjects are enrolled in this clinical investigation?

"Affirmative. Clinical trials website data indicates that this investigation is actively enrolling participants and was initially uploaded on September 13th 2018. The most recent edit to the trial's page occurred November 16th 2022, with 40 individuals required at a single site."

Answered by AI

Has the FDA sanctioned Vitamin B6?

"The safety of Vitamin B6 is estimated at a 2 since the current Phase 2 trial has gathered evidence in regards to its security, yet there are no studies exploring its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03580499.

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