NCT03580499Completed
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 15 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 29 Jun 2018
- Start date
- 13 Sept 2018
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT03580499
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 13 Sept 2018 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Subjects without a diagnosis of prostate cancer
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.