Sildenafil for Cancer-Related Cognitive Impairment
(SPARC Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMelinda Sheffield-Moore, PhD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: The University of Texas Medical Branch, Galveston
Must not be taking: Alpha blockers, PDE5 inhibitors, Nitrates
Disqualifiers: Untreated thyroid, Diabetes, BMI >30, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, such as alpha blockers, PDE5 inhibitors, and nitrates, as they are not allowed in the trial. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.
Is Sildenafil safe for humans?
Sildenafil, commonly known as Viagra, has been widely used and studied for treating erectile dysfunction and pulmonary hypertension (high blood pressure in the lungs). It is generally considered safe for these conditions, but like any medication, it can have side effects such as headaches, flushing, or upset stomach. Always consult with a healthcare provider for personalized advice.
12345How does the drug Sildenafil differ from other treatments for cancer-related cognitive impairment?
Sildenafil, commonly known for treating erectile dysfunction, is unique in this context as it may improve blood flow and potentially enhance cognitive function, unlike traditional treatments for cancer-related cognitive impairment which often focus on managing symptoms with stimulants or mood stabilizers.
12678Eligibility Criteria
This trial is for women aged 30-50 with ER+/HER2- breast cancer who've had a menstrual cycle in the past year and can follow study procedures. Excluded are those with untreated diabetes or thyroid issues, high BMI, certain medical devices, neuromuscular diseases, prior cognitive impairment or chemotherapy, severe claustrophobia, specific medication use recently (alpha blockers, PDE5 inhibitors), extreme blood pressure levels, neurovascular disease or HIV/Hepatitis.Inclusion Criteria
Self-reported menses occurrence within past 12 months
My breast cancer is ER positive and HER2 negative.
Willing and able to provide consent
+3 more
Exclusion Criteria
I have diabetes that has not been treated.
My BMI is over 30.
I have a thyroid condition that hasn't been treated.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neoadjuvant Chemotherapy
Participants receive neoadjuvant chemotherapy treatment
20 weeks
Surgery
Participants undergo surgery as part of the standard of care treatment
4 weeks
Radiation Treatment
Participants receive radiation treatment
6 weeks
Chemotherapy
Participants receive chemotherapy treatment
20 weeks
Endocrine Treatment
Participants receive 24 weeks of endocrine treatment
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study investigates how standard cancer care combined with Sildenafil affects fatigue related to cancer treatment, cognitive function and gut microbiome health in young women undergoing treatment for breast cancer.
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care Treatment and SildenafilExperimental Treatment1 Intervention
Sildenafil, 50mg, daily for duration of the standard of care treatment
Group II: Standard of Care TreatmentActive Control1 Intervention
standard of care treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Medical BranchGalveston, TX
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Who Is Running the Clinical Trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
References
The impact of cancer therapy on cognition in the elderly. [2021]Cancer and cancer therapy-related cognitive impairment (formerly known as chemobrain or chemo-fog) are often described in the literature. In the past, studies have failed to prove the existence of cancer therapy-related cognitive dysfunction. However, more recently, prospective trials have shown that patients undergoing chemotherapy do display impairment in specific cognitive domains. Aging confers an increased risk of developing cancer, as well as cognitive impairment. The Geriatric Oncology clinic of the Segal Cancer Centre, Jewish General Hospital in Montreal was founded in 2006 to address the unique needs of older cancer patients. We will describe two cases of cancer therapy-related cognitive impairment from our Geriatric Oncology clinic. The first case is that of a 75 year old male diagnosed with stage III non-small cell lung carcinoma who complained of forgetfulness since starting carboplatin-paclitaxel. The second case is that of a 65 year old female diagnosed with stage I, estrogen-receptor-positive breast cancer who had undergone lumpectomy followed by adjuvant cyclophosphamide, methotrexate and fluorouracil chemotherapy, radiation therapy and was on exemestane when she was evaluated. We will also briefly review the literature of cancer therapy-related cognitive impairment.
Memory loss during lenalidomide treatment: a report on two cases. [2021]There are many reports of cognitive dysfunction in patients receiving chemotherapy or targeted therapies. Many antineoplastic agents may be involved in the condition also known as "chemo brain" or "chemo fog".
Chemotherapy-Induced Cognitive Impairment. [2023]Terms such as "chemobrain" or "chemofog" may be familiar to many patients with cancer. Specific chemotherapy agents are known to cause chemotherapy-induced cognitive impairment (CICI). Interventions to prevent or redu.
The effect of cancer treatment on cognitive function. [2022]Cognitive dysfunction is an increasingly recognized complication of cancer and its treatment. Most research in this arena has found that a subset of patients appear to be vulnerable to this complication even after treatment has ended, and often have difficulties with multitasking, short-term memory, word-finding, attention, or concentration. The mechanisms underlying these cognitive changes are not fully elucidated but may include direct neurotoxic effects of therapy, oxidative damage, and genetic predisposition. Compelling evidence has accumulated for the role of immune dysregulation and neurotoxicity from inflammatory cytokines. A gold standard for subjective or objective assessment of cancer treatment-related cognitive changes has yet to be established. Current options to assess cognitive function include neuropsychological testing, functional neuroimaging, and subjective assessments. Pharmacologic treatment options for this clinical problem are modest and limited. Nonpharmacologic treatments, including cognitive rehabilitation programs, are an emerging area of research for the management of cancer treatment-related cognitive changes.
Evidence-based interventions for cancer- and treatment-related cognitive impairment. [2022]Cancer- and cancer treatment-related cognitive impairment is a common, bothersome, and potentially debilitating symptom incurred by cancer survivors. Cognitive impairment has a significant impact on patients' day-to-day functioning and quality of life, but it remains under-recognized and undertreated. This article, which is an update from the initial Oncology Nursing Society Putting Evidence Into Practice for cancer- and cancer treatment-related cognitive impairment, provides a comprehensive critical review and summary of the evidence regarding interventions addressing cognitive impairment for cancer survivors. This article examines the effectiveness of interventions focused on cancer- and cancer treatment-related cognitive impairment, makes recommendations for practice, and identifies gaps in knowledge and areas for further research.
Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. [2023]To examine the effect of interventions used to enhance cognitive function in patients experiencing cancer-related cognitive impairment.
Emerging pharmacotherapy for cancer patients with cognitive dysfunction. [2022]Advances in the diagnosis and multi-modality treatment of cancer have increased survival rates for many cancer types leading to an increasing load of long-term sequelae of therapy, including that of cognitive dysfunction. The cytotoxic nature of chemotherapeutic agents may also reduce neurogenesis, a key component of the physiology of memory and cognition, with ramifications for the patient's mood and other cognition disorders. Similarly radiotherapy employed as a therapeutic or prophylactic tool in the treatment of primary or metastatic disease may significantly affect cognition. A number of emerging pharmacotherapies are under investigation for the treatment of cognitive dysfunction experienced by cancer patients. Recent data from clinical trials is reviewed involving the stimulants modafinil and methylphenidate, mood stabiliser lithium, anti-Alzheimer's drugs memantine and donepezil, as well as other agents which are currently being explored within dementia, animal, and cell culture models to evaluate their use in treating cognitive dysfunction.
[An overview of the research of cancer-related cognitive impairment]. [2019]A significant proportion of cancer patients reports a decline in their usual cognitive functions. This impairment may be the consequence of either the malignant disorder itself or the side-effect of the treatment. This impairment in cognitive skills was referred to with a sticky witty name as chemobrain or chemofog, reflecting on the old conception based on the assumption that solely the neurotoxic effect of chemotherapy was responsible for this kind of disturbances. However, today there is increasing evidence proving that such hypotheses can only partially explain the cognitive decline of cancer patients and cancer survivors. As a matter of fact, the cognitive impairment of cancer patients is a much more complex consequence of the malignant disorder than chemobrain or chemofog. Nowadays, this process is described as "cancer-related cognitive impairment" (CRCI). Orv Hetil. 2019; 160(38): 1495-1502.