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Aspirin for Ovarian Cancer

Phase < 1
Recruiting
Led By Jing-Yi Chern, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants that are greater than or equal to 18 years of age
Estimated creatinine clearance of > 30 mL/min, calculated using the formula Cockcroft-Gault [(140-age) x Mass (kg)/(72 x creatinine mg/dL)] x 0.85 for female
Must not have
Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.
Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 months

Summary

This trial is testing whether aspirin can decrease markers of immune suppression in ovarian cancer patients receiving chemotherapy.

Who is the study for?
This trial is for women aged 18+ with ovarian, fallopian tube, or peritoneal carcinoma who haven't started treatment. They must be able to read English/Spanish (U.S.) or English/French (Canada), have a certain disease severity and type, plan to undergo specific chemotherapy followed by surgery, and meet health criteria like blood counts and organ function.
What is being tested?
The study tests if aspirin can boost the immune system's response to tumors when given with standard chemo before surgery in patients with certain types of female reproductive cancers. Participants will either receive aspirin or a placebo alongside their chemotherapy regimen.
What are the potential side effects?
Aspirin may cause risks such as bleeding issues, digestive tract irritation like ulcers, allergic reactions in those sensitive to NSAIDs, and potential complications for those with clotting disorders or severe liver/renal conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidneys work well enough, based on a creatinine clearance test.
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I am set to receive specific chemotherapy before surgery for 3-5 cycles.
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My cancer is a type of ovarian, fallopian tube, or peritoneal and is grade 2 or higher.
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I have not received any treatment for my current cancer diagnosis.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot swallow pills and have stomach issues that could affect medication absorption.
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I have not been diagnosed with any cancer other than non-melanoma skin cancer in the last 3 years.
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I have severe esophagitis that hasn't improved with two treatments.
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I have had weight loss surgery in the past.
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I haven't had a heart attack, stroke, or major heart surgery in the last year.
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I am on medication for an autoimmune disease.
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I am allergic to aspirin or NSAIDs.
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I cannot take aspirin due to ulcers, severe liver failure, or kidney disease.
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I have a known G6PD deficiency or a specific metabolism type (CYP2C9).
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I haven't had any serious bleeding issues in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery
Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery
Secondary study objectives
Change in blood levels of CA 125
Change in blood levels of IL-6
Change in blood levels of p-selectin
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants Randomized to AspirinExperimental Treatment1 Intervention
Participants randomized to this arm will receive 325mg daily dose aspirin
Group II: Participants Randomized to PlaceboPlacebo Group1 Intervention
Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 325mg
2019
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Sharp Clinical Services, IncUNKNOWN
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,748 Total Patients Enrolled
10 Trials studying Ovarian Cancer
517 Patients Enrolled for Ovarian Cancer
United States Department of DefenseFED
910 Previous Clinical Trials
333,631 Total Patients Enrolled
7 Trials studying Ovarian Cancer
1,945 Patients Enrolled for Ovarian Cancer

Media Library

Aspirin 325mg Clinical Trial Eligibility Overview. Trial Name: NCT05080946 — Phase < 1
Ovarian Cancer Research Study Groups: Participants Randomized to Aspirin, Participants Randomized to Placebo
Ovarian Cancer Clinical Trial 2023: Aspirin 325mg Highlights & Side Effects. Trial Name: NCT05080946 — Phase < 1
Aspirin 325mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05080946 — Phase < 1
~12 spots leftby May 2025
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