Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment

ConditionCancer
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age30-50
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Ages 30 - 50 years

Self-reported menses occurrence within past 12 months

Diagnosis of ER+/HER2- breast cancer

Disqualifiers

Untreated thyroid disorder

Untreated diabetes

BMI >30

Current treatment with metformin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sildenafil

    Drug

    Sildenafil, 50mg, daily

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Standard of Care TreatmentNo intervention 0 interventions
Group B: Standard of Care Treatment and SildenafilExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
through neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline
3

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.

Time frame
through completion of surgery, average of 24 weeks from baseline
4

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.

Time frame
through radiation treatment completion, average of 30 weeks from baseline

Secondary outcomes

1

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

Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

Time frame
baseline
2

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

Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

Time frame
through neoadjuvant chemotherapy treatment completion, average of 20 weeks from baseline
3

Quantify absolute abundance of gut microbiome using metagenomic analysis after surgery

Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

Time frame
through completion of surgery, average of 24 weeks from baseline
4

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

Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.

Time frame
through radiation treatment completion, average of 30 weeks from baseline

Other outcomes

Sponsors and contacts

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