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Sildenafil for Cancer-Related Cognitive Impairment

This study is looking at how a medication called Sildenafil (50mg daily) affects "brain fog" (cancer-related cognitive impairment) and fatigue in women undergoing standard breast cancer treatment. Researchers want to understand if Sildenafil can help reduce these symptoms, which often include problems with memory, learning, and thinking clearly. They are also studying how standard cancer treatments impact these issues and the gut microbiome. To join, you must be a woman between 30 and 50 years old with ER+/HER2- breast cancer who has had a period in the last year. The study will measure your fatigue and thinking abilities at the start, after chemotherapy, and after surgery to see if Sildenafil makes a difference. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your fatigue and cognition will be measured at baseline, through neoadjuvant chemotherapy treatment completion (average of 20 weeks), and through completion of surgery (average of 24 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06800092

Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment

Not Yet Recruiting
PHASE2Ages 30–50InterventionalSupportive care
The University of Texas Medical Branch, Galveston
~30 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Sildenafil

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline
Measured over Baseline
+17 more outcomes measured

Conditions

Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Kate Randolph, BS
[email protected]
409-223-7891
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baselineBaseline

    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.

  • Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after neoadjuvant chemotherapy treatmentthrough neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline

    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.

  • Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after surgerythrough completion of surgery, average of 24 weeks from baseline

    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.

  • Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after radiation treatmentthrough radiation treatment completion, average of 30 weeks from baseline

    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.

  • Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after chemotherapy treatmentthrough chemotherapy treatment completion, average of 50 weeks from baseline

    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.

  • Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after 24 weeks of endocrine treatmentthrough 24 weeks of endocrine treatment, average of 74 weeks from baseline

    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.

  • Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) at baselinebaseline

    The FACT-Cog is a self-administered measure of perceived cognitive impairment for patients undergoing cancer therapy. The FACT-Cog (version 3) contains 37 items which quantify 4 subscale domains using a 5 point Likert-type scale including: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others and perceived cognitive abilities. Perceived cognitive impairments subscale will be reported (range: 0-72, with a higher score indicating better quality of life).

  • Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after neoadjuvant chemotherapy treatmentthrough neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline

    The FACT-Cog is a self-administered measure of perceived cognitive impairment for patients undergoing cancer therapy. The FACT-Cog (version 3) contains 37 items which quantify 4 subscale domains using a 5 point Likert-type scale including: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others and perceived cognitive abilities. Perceived cognitive impairments subscale will be reported (range: 0-72, with a higher score indicating better quality of life).

  • Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after surgerythrough completion of surgery, average of 24 weeks from baseline

    The FACT-Cog is a self-administered measure of perceived cognitive impairment for patients undergoing cancer therapy. The FACT-Cog (version 3) contains 37 items which quantify 4 subscale domains using a 5 point Likert-type scale including: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others and perceived cognitive abilities. Perceived cognitive impairments subscale will be reported (range: 0-72, with a higher score indicating better quality of life).

  • Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after radiation treatmentthrough radiation treatment completion, average of 30 weeks from baseline

    The FACT-Cog is a self-administered measure of perceived cognitive impairment for patients undergoing cancer therapy. The FACT-Cog (version 3) contains 37 items which quantify 4 subscale domains using a 5 point Likert-type scale including: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others and perceived cognitive abilities. Perceived cognitive impairments subscale will be reported (range: 0-72, with a higher score indicating better quality of life).

  • Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after chemotherapy treatmentthrough chemotherapy treatment completion, average of 50 weeks from baseline

    The FACT-Cog is a self-administered measure of perceived cognitive impairment for patients undergoing cancer therapy. The FACT-Cog (version 3) contains 37 items which quantify 4 subscale domains using a 5 point Likert-type scale including: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others and perceived cognitive abilities. Perceived cognitive impairments subscale will be reported (range: 0-72, with a higher score indicating better quality of life).

  • Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after 24 weeks of endocrine therapy treatmentthrough 24 weeks of endocrine treatment, average of 74 weeks from baseline

    The FACT-Cog is a self-administered measure of perceived cognitive impairment for patients undergoing cancer therapy. The FACT-Cog (version 3) contains 37 items which quantify 4 subscale domains using a 5 point Likert-type scale including: perceived cognitive impairments, impact of perceived cognitive impairments on quality of life, comments from others and perceived cognitive abilities. Perceived cognitive impairments subscale will be reported (range: 0-72, with a higher score indicating better quality of life).

  • Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) at baselinebaseline

    Perceptual fatigue will be assessed using the Brief Fatigue Inventory (BFI), a 9-item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life). The scores from all 9 questions can be average to calculate a Global Fatigue Score, with a range from 0 to 10, with a higher score indicating more fatigue.

  • Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after neoadjuvant chemotherapy treatmentthrough neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline

    Perceptual fatigue will be assessed using the Brief Fatigue Inventory (BFI), a 9-item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life). The scores from all 9 questions can be average to calculate a Global Fatigue Score, with a range from 0 to 10, with a higher score indicating more fatigue.

  • Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after surgerythrough completion of surgery, average of 24 weeks from baseline

    Perceptual fatigue will be assessed using the Brief Fatigue Inventory (BFI), a 9-item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life). The scores from all 9 questions can be average to calculate a Global Fatigue Score, with a range from 0 to 10, with a higher score indicating more fatigue.

  • Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after radiation treatmentthrough radiation treatment completion, average of 30 weeks from baseline

    Perceptual fatigue will be assessed using the Brief Fatigue Inventory (BFI), a 9-item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life). The scores from all 9 questions can be average to calculate a Global Fatigue Score, with a range from 0 to 10, with a higher score indicating more fatigue.

  • Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after chemotherapy treatmentthrough chemotherapy treatment completion, average of 50 weeks from baseline

    Perceptual fatigue will be assessed using the Brief Fatigue Inventory (BFI), a 9-item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life). The scores from all 9 questions can be average to calculate a Global Fatigue Score, with a range from 0 to 10, with a higher score indicating more fatigue.

  • Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after 24 weeks of endocrine treatmentthrough 24 weeks of endocrine treatment, average of 74 weeks from baseline

    Perceptual fatigue will be assessed using the Brief Fatigue Inventory (BFI), a 9-item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life). The scores from all 9 questions can be average to calculate a Global Fatigue Score, with a range from 0 to 10, with a higher score indicating more fatigue.