Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Prostate Carcinoma Dietary Supplement: Vitamin B6 Phase 2

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]).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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 : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (vitamin B6)
Participants receive vitamin B6 PO daily for 12 weeks.
Dietary Supplement: Vitamin B6
Given PO
Other Names:
  • 8059-24-3
  • VIT B6
  • Vitamin B-6
  • Vitamin B 6




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Anne Calvaresi, MSN 215-955-1000 anne.calvaresi@jefferson.edu

Locations
Layout table for location information
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Mark Hurwitz, MD         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Layout table for investigator information
Principal Investigator: Mark Hurwitz, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
Additional Information:
Layout table for additonal information
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03580499    
Other Study ID Numbers: 18D.273
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs