Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Cognitive Impairment, Malignant Neoplasm

In brief

This randomized phase II trial studies how well low-dose ibuprofen in improving cognitive impairment in patients with cancer. Anti-inflammatory agents, such as ibuprofen, may slow the decline of cognitive processes and diseases involving the brain.

Key facts

Study ID

NCT03186638

Run by

University of Rochester NCORP Research Base

People needed

87

Starts

2017-05-26

Expected to finish

2022-06-01

Last updated by the study team

2023-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of cancer and have had surgery and are now receiving adjuvant or neoadjuvant chemotherapy or who have received chemotherapy within the last 6 months; chemotherapy with concurrent radiation therapy (RT) is allowed
• Answer YES to the question: "Have you noticed any problems in your memory, attention, concentration, multi-tasking or other cognitive functions?" any time after initiation of chemotherapy cycle 1
• NOTE: If a participant answers NO, they may be re-approached at a subsequent cycle
• Be able to swallow medication
• Be able to read English
• Have the ability to understand and to give written informed consent as assessed by the participant's primary care physician or medical oncologist

You may not qualify if…

• Have a confirmed brain tumor or brain metastases
• Be taking a regular daily dose of an NSAID NOTE: Daily doses of 81 mg aspirin are permitted and higher doses of an NSAID on an 'as needed' basis are permitted
• Be diagnosed with dementia or severe neurodegenerative disease
• Have a contraindication to NSAIDs at the oncologist's discretion (i.e., allergy, worsening of ongoing medical problem due to NSAID, very low platelet count from chemotherapy, full-dose anti-coagulation/high risk of bleeding, and uncontrolled conditions such as hypertension, asthma, or peptic ulcer disease)
• Have been hospitalized for treatment of a major psychiatric illness within the last five years
• Have a serum creatinine above 1.5 upper limit of normal (ULN) (collected within the past 4 weeks); ULN is per institutional definition
• Concurrent administration of warfarin, full dose aspirin, clopidogrel, apixaban or other medications known to increase the risk of bleeding or to interfere with antiplatelet activities
• Be colorblind
• Have active substance abuse (e.g. alcohol, drugs) per self-report or medical record

Where it is running

• Beebe Medical Center — Lewes, Delaware, United States
• Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Regional Hematology and Oncology PA — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• Nanticoke Memorial Hospital — Seaford, Delaware, United States
• Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States
• Saint Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• Saint Luke's Mountain States Tumor Institute - Fruitland — Fruitland, Idaho, United States
• Saint Luke's Mountain States Tumor Institute - Meridian — Meridian, Idaho, United States
• Saint Luke's Mountain States Tumor Institute - Nampa — Nampa, Idaho, United States
• Saint Luke's Mountain States Tumor Institute-Twin Falls — Twin Falls, Idaho, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Memorial Hospital of Carbondale — Carbondale, Illinois, United States
• SIH Cancer Institute — Carterville, Illinois, United States
• Illinois CancerCare-Carthage — Carthage, Illinois, United States
• Centralia Oncology Clinic — Centralia, Illinois, United States
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Crossroads Cancer Center — Effingham, Illinois, United States
• Illinois CancerCare-Eureka — Eureka, Illinois, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.