RECRUITING

Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment

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Conditions

CancerFatigueBrain Fog

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is examining the effects of standard of care cancer treatment as well as a medication called Sildenafil, on the cancer associated fatigue, cognition and the gut microbiome.

Official Title

Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment

Quick Facts

Study Start:2025-02-15
Study Completion:2030-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06800092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Ages 30 - 50 years
  3. * Self-reported menses occurrence within past 12 months
  4. * Diagnosis of ER+/HER2- breast cancer
  5. * Willing and able to comply with study procedures
  6. * Willing and able to provide consent
  1. * Untreated thyroid disorder
  2. * Untreated diabetes
  3. * BMI \>30
  4. * Current treatment with metformin
  5. * Diagnosed neuromuscular disease
  6. * Diagnosed neurovascular disease
  7. * Prior history of cognitive impairment
  8. * Prior history of chemotherapy treatment
  9. * HIV, Hepatitis B or Hepatitis C
  10. * Systolic blood pressure \<90 or \>170, diastolic blood pressure \<50 or \>110 after repeated evaluation with proper cuff. This range is the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110)
  11. * Use of alpha blockers in the past 2 weeks
  12. * Use of PDE5 inhibitors in the past 2 weeks
  13. * Use of nitrates
  14. * Subjects with MRI incompatible devices
  15. * Subjects with severe claustrophobia
  16. * Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation

Contacts and Locations

Study Contact

Kate Randolph, BS
CONTACT
409-223-7891
kmrandol@utmb.edu
Christopher Danesi, MA
CONTACT
409-772-8126
cpdanesi@utmb.edu

Principal Investigator

Melinda Sheffield-Moore, PhD
PRINCIPAL_INVESTIGATOR
University of Texas

Study Locations (Sites)

The University of Texas Medical Branch
Galveston, Texas, 77555
United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

  • Melinda Sheffield-Moore, PhD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-15
Study Completion Date2030-06-01

Study Record Updates

Study Start Date2025-02-15
Study Completion Date2030-06-01

Terms related to this study

Keywords Provided by Researchers

  • Fatigue
  • Brain Fog

Additional Relevant MeSH Terms

  • Cancer