Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment

NCT06800092 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 24-0247
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

Fatigue; Brain Fog

Outcome Measures

Primary Outcomes (18)

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

  Baseline

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after neoadjuvant chemotherapy treatment

  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.

  through neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after surgery

  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.

  through completion of surgery, average of 24 weeks from baseline

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after radiation treatment

  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.

  through radiation treatment completion, average of 30 weeks from baseline

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after chemotherapy treatment

  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.

  through chemotherapy treatment completion, average of 50 weeks from baseline

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after 24 weeks of endocrine treatment

  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.

  through 24 weeks of endocrine treatment, average of 74 weeks from baseline

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

  baseline

• Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after neoadjuvant chemotherapy treatment

  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).

  through neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline

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

  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).

  through completion of surgery, average of 24 weeks from baseline

• Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after radiation treatment

  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).

  through radiation treatment completion, average of 30 weeks from baseline

• Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after chemotherapy treatment

  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).

  through chemotherapy treatment completion, average of 50 weeks from baseline

• Perceived Cognition measured by the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog) after 24 weeks of endocrine therapy treatment

  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).

  through 24 weeks of endocrine treatment, average of 74 weeks from baseline

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

  baseline

• Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after neoadjuvant chemotherapy treatment

  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.

  through neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline

• Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after surgery

  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.

  through completion of surgery, average of 24 weeks from baseline

• Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after radiation treatment

  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.

  through radiation treatment completion, average of 30 weeks from baseline

• Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after chemotherapy treatment

  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.

  through chemotherapy treatment completion, average of 50 weeks from baseline

• Perceptual Fatigue as measured by the MD Anderson Brief Fatigue Inventory (BFI) after 24 weeks of endocrine treatment

  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.

  through 24 weeks of endocrine treatment, average of 74 weeks from baseline

Secondary Outcomes (11)

• Quantify absolute abundance of gut microbiome using using metagenomic analysis at baseline

  baseline

• Quantify absolute abundance of gut microbiome using metagenomic analysis after neoadjuvant chemotherapy treatment

  through neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline

• Quantify absolute abundance of gut microbiome using metagenomic analysis after surgery

  through completion of surgery, average of 24 weeks from baseline

• Quantify absolute abundance of gut microbiome using metagenomic analysis after radiation treatment

  through radiation treatment completion, average of 30 weeks from baseline

• Quantify absolute abundance of gut microbiome using metagenomic analysis after chemotherapy treatment

  through chemotherapy treatment completion, average of 50 weeks from baseline

Study Arms (2)

Standard of Care Treatment

NO INTERVENTION

standard of care treatment

Standard of Care Treatment and Sildenafil

EXPERIMENTAL

Sildenafil, 50mg, daily for duration of the standard of care treatment

Drug: Sildenafil

Interventions

Sildenafil DRUG

Sildenafil, 50mg, daily

Also known as: Viagra

Standard of Care Treatment and Sildenafil

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Neoplasms; Fatigue; Mental Fatigue

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Melinda Sheffield-Moore, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Randolph, BS

CONTACT

409-223-7891; kmrandol@utmb.edu

Christopher Danesi, MA

CONTACT

409-772-8126; cpdanesi@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 29, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)