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Vitamin B6 for Hot Flashes in Prostate Cancer

N/A
Waitlist Available
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
Must not have
Subjects already receiving other treatment for hot flashes
Subjects taking selective serotonin reuptake inhibitors (SSRIs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
No Placebo-Only Group

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for hot flashes.
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I am currently taking SSRIs for my mental health.
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I am currently taking vitamin supplements that include more than 10 mg of vitamin B6.
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I have not been diagnosed with prostate cancer.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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
8%
Vasovagal reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin B6 Effects in OC Users

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~570

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
163 Previous Clinical Trials
10,977 Total Patients Enrolled
11 Trials studying Prostate Cancer
1,425 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
~6 spots leftby Nov 2025
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