Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer
Condition: Cognitive Impairment; Malignant Neoplasm
MeSH terms: Neoplasms; Cognitive Dysfunction
Intervention: Ibuprofen; Placebo; Questionnaire Administration
Intervention description: Given PO; Given PO; Ancillary studies
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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