Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03580499|
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : November 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hot Flashes Prostate Carcinoma||Dietary Supplement: Vitamin B6||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients|
|Actual Study Start Date :||September 13, 2018|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Supportive Care (vitamin B6)
Participants receive vitamin B6 PO daily for 12 weeks.
Dietary Supplement: Vitamin B6
- Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe) [ Time Frame: 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.
- Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580499
|Contact: Anne Calvaresi, MSNemail@example.com|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator: Anne Calvaresi, MSN|
|Principal Investigator:||Anne Calvaresi, MSN||Sidney Kimmel Cancer Center at Thomas Jefferson University|