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

Study Overview
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Brief Summary
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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
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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]).

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

Conditions
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Hot Flashes, Prostate Carcinoma

Intervention / Treatment
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* Dietary Supplement: Vitamin B6


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (vitamin B6)<br>Participants receive vitamin B6 PO daily for 12 weeks. | Dietary Supplement: Vitamin B6<br>* Given PO<br>* Other names: Vitamin B 6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 12 weeks |