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

Completed · Not applicable

Conditions studied: Hot Flashes, Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT03580499

Run by

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

People needed

43

Starts

2018-09-13

Expected to finish

2024-07-01

Last updated by the study team

2025-10-15

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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