Status:

TERMINATED

Anti-anxiety Biotics for Breast Cancer Survivors

Lead Sponsor:

Auburn University

Collaborating Sponsors:

National Center for Advancing Translational Sciences (NCATS)

Conditions:

Anxiety Generalized

Breast Cancer Female

Eligibility:

FEMALE

50+ years

Phase:

NA

Brief Summary

Cancer survivors experience more rapid declines in health-related quality of life which include physical and psychological comorbidities, the latter of which may be subclinical and often overlooked by...

Eligibility Criteria

Inclusion

  • Female breast cancer survivors or female relatives of a breast cancer survivor who:
  • are 50 years of age or older
  • have completed primary treatment
  • currently experience clinical anxiety symptoms determined by the 7 item Generalized Anxiety Disorder screener (GAD-7; eligibility requires a total score of 5 or higher on the 21 point scale)
  • agree not to change dietary supplements throughout the course of the study
  • are willing to comply with daily supplement regimen
  • are able to speak and read English.

Exclusion

  • use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics
  • changes in treatment for anxiety symptoms (i.e. initiation of Cognitive Behavior Therapy (CBT) within the last four weeks
  • current use (within 12 weeks) of anxiolytic medications.

Key Trial Info

Start Date :

July 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2022

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT04784182

Start Date

July 20 2021

End Date

May 1 2022

Last Update

August 24 2023

Active Locations (1)

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1

Auburn University

Auburn, Alabama, United States, 36849