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

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ClinicalTrials.gov Identifier: NCT03580499
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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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]).

Study Design
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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 : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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
Contacts and Locations
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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
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Contact: Anne Calvaresi, MSN 215-955-1000 anne.calvaresi@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Anne Calvaresi, MSN         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Anne Calvaresi, MSN Sidney Kimmel Cancer Center at Thomas Jefferson University
More Information
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Additional Information:

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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: November 17, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Physiological Effects of Drugs