Using Sildenafil to Help with Cancer-Related Cognitive Issues
Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment
PHASE2; PHASE3 · The University of Texas Medical Branch, Galveston · NCT06800092
This study is testing if Sildenafil can help breast cancer patients with cognitive issues and fatigue caused by their cancer treatments.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | Female |
| Sponsor | The University of Texas Medical Branch, Galveston (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT06800092 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Sildenafil, alongside standard cancer treatments, on cognitive impairment and fatigue associated with cancer. It focuses on understanding how cancer therapies impact neurocognitive function, particularly in breast cancer patients experiencing 'chemo-brain' or brain fog. The study aims to explore the relationship between cognitive decline, inflammation, and the gut microbiome, as well as the potential of Sildenafil to mitigate these effects. Participants will be closely monitored for changes in cognitive function and overall well-being throughout the treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 30 to 50 with a diagnosis of ER+/HER2- breast cancer who have experienced recent menstrual cycles.
Not a fit: Patients with untreated thyroid disorders, diabetes, or prior cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to alleviate cognitive impairment and fatigue in cancer patients.
How similar studies have performed: While the approach of using Sildenafil for cognitive impairment in cancer patients is novel, other studies have explored cognitive interventions in cancer care with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Ages 30 - 50 years * Self-reported menses occurrence within past 12 months * Diagnosis of ER+/HER2- breast cancer * Willing and able to comply with study procedures * Willing and able to provide consent Exclusion Criteria: * Untreated thyroid disorder * Untreated diabetes * BMI \>30 * Current treatment with metformin * Diagnosed neuromuscular disease * Diagnosed neurovascular disease * Prior history of cognitive impairment * Prior history of chemotherapy treatment * HIV, Hepatitis B or Hepatitis C * 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) * Use of alpha blockers in the past 2 weeks * Use of PDE5 inhibitors in the past 2 weeks * Use of nitrates * Subjects with MRI incompatible devices * Subjects with severe claustrophobia * Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
Where this trial is running
Galveston, Texas
- The University of Texas Medical Branch — Galveston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Melinda Sheffield-Moore, PhD — University of Texas
- Study coordinator: Kate Randolph, BS
- Email: kmrandol@utmb.edu
- Phone: 409-223-7891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Fatigue, Brain Fog