Clinical trial · Interventional
Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment
NCT06800092CI-TRIAL-00111066SPARCnot yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sildenafil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care Treatment
- description
- standard of care treatment
- type
- EXPERIMENTAL
- label
- Standard of Care Treatment and Sildenafil
- description
- Sildenafil, 50mg, daily for duration of the standard of care treatment
- interventionNames
- Drug: Sildenafil
Primary outcomes (18)
- measure
- Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline
- timeFrame
- Baseline
- description
- The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition. There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.