Hot Flashes, Prostate Carcinoma
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin B6
Given PO
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed