Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

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]).


Criteria:

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


Study is Available At:


Original ID:

18D.273


NCT ID:

NCT03580499


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Thomas Jefferson University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Mark Hurwitz, MD
Principal Investigator
Sidney Kimmel Cancer Center at Thomas Jefferson University
Primary Contact:Anne Calvaresi, MSN
215-955-1000
anne.calvaresi@jefferson.edu

Study Dates

Start Date:September 13, 2018
Completion Date:February 2021
Completion Type:Anticipated
Primary Completion Date:February 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 14, 2019
First Received Date:June 29, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:The same approach will be used for the secondary analysis of 12-week post-treatment responses in comparison to the pre-treatment responses.
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Dietary Supplement
Name:Vitamin B6
Description:Given PO
Arm Name:Supportive Care (vitamin B6)
Other Name:8059-24-3

Study Arms

Study Arm Type:Experimental
Arm Name:Supportive Care (vitamin B6)
Description:Participants receive vitamin B6 PO daily for 12 weeks.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sidney Kimmel Cancer Center at Thomas Jefferson University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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