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

Not Applicable

Completed

• Conditions: Hot Flashes; Prostate Carcinoma
• Interventions: Dietary Supplement: Vitamin B6; Other: Questionnaire Administration

• Registration Number: NCT03580499
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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 \[ADT\]).

OUTLINE:

Participants receive vitamin B6 orally (PO) daily for 12 weeks.

Study Timeline

• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-09
• Study Start: 2018-09-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (vitamin B6)	Vitamin B6	Participants receive vitamin B6 PO daily for 12 weeks.
Supportive Care (vitamin B6)	Questionnaire Administration	Participants receive vitamin B6 PO daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)	Baseline to 8 weeks	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

Name	Time	Method
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)	Baseline to 12 weeks	The same approach will be used for the secondary analysis of 12-week post-treatment responses in comparison to the pre-treatment responses.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States