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

• Status: Recruiting
• Trial end date: 2022-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary Morrow; University of Rochester NCORP Research Base
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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