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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
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 belowSelect...
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
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 • NCT011282448%
Vasovagal reaction
100%
80%
60%
40%
20%
0%
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
~570
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on hormone therapy for prostate cancer and experience hot flashes.I am currently being treated for hot flashes.I am currently taking SSRIs for my mental health.I am currently taking vitamin supplements that include more than 10 mg of vitamin B6.I am experiencing significant hot flashes.I am able to understand and agree to the study's procedures and risks.I have not been diagnosed with prostate cancer.I am on hormone therapy for prostate cancer and will continue it for at least 13 weeks after joining.I am willing and able to follow all study rules and attend all appointments.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (vitamin B6)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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