Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a medication called Sildenafil can help improve memory and reduce fatigue in women being treated for breast cancer. The study also looks at how cancer treatment affects the gut microbiome, which is the community of bacteria and other microorganisms in our digestive system. They are currently looking for women aged 30 to 50 who have been diagnosed with a specific type of breast cancer (ER+/HER2-) and have had their menstrual cycle in the past year.

To participate in the study, women must be willing to follow the study procedures and give their consent. However, there are some health conditions that would prevent someone from joining, such as untreated thyroid or diabetes issues, certain heart conditions, or a history of cognitive impairment. Participants can expect to receive standard cancer treatment along with Sildenafil while being monitored for any changes in their fatigue and cognitive abilities. If you think you might be eligible and are interested in joining, this could be an opportunity to contribute to important research that may help others in the future.

Gender

FEMALE

Eligibility 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