Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Hot Flash |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/17/2019 |
| Start Date: | September 13, 2018 |
| End Date: | February 2021 |
| Contact: | Anne Calvaresi, MSN |
| Email: | anne.calvaresi@jefferson.edu |
| Phone: | 215-955-1000 |
A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients
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.
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.
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]).
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]).
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
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
Principal Investigator: Mark Hurwitz, MD
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