Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
Primary Purpose
Hot Flashes, Prostate Carcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin B6
Sponsored by
About this trial
This is an interventional supportive care trial for Hot Flashes
Eligibility 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
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (vitamin B6)
Arm Description
Participants receive vitamin B6 PO daily for 12 weeks.
Outcomes
Primary Outcome Measures
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
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 will be tested using a two-sided Wilcoxon Signed-Rank Test with alpha=0.05.
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)
The same approach will be used for the secondary analysis of 12-week post-treatment responses in comparison to the pre-treatment responses.
Full Information
NCT ID
NCT03580499
First Posted
June 29, 2018
Last Updated
October 6, 2023
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT03580499
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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]).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Prostate Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (vitamin B6)
Arm Type
Experimental
Arm Description
Participants receive vitamin B6 PO daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin B6
Other Intervention Name(s)
8059-24-3, VIT B6, Vitamin B-6, Vitamin B 6
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
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 will be tested using a two-sided Wilcoxon Signed-Rank Test with alpha=0.05.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
Description
The same approach will be used for the secondary analysis of 12-week post-treatment responses in comparison to the pre-treatment responses.
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Costas Lallas, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
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