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

University of Rochester NCORP Research Base

Status and phase: Completed; Phase 2

Conditions: Malignant Neoplasm; Cognitive Impairment

Treatments: Other: Questionnaire Administration; Other: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03186638

UG1CA189961 (U.S. NIH Grant/Contract)

URCC-16092 (Other Identifier)

NCI-2017-00790 (Registry Identifier)

R21CA187500 (U.S. NIH Grant/Contract)

URCC16092 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To provide preliminary data on the effect of ibuprofen on alleviating chemotherapy-related cognitive impairment (CRCI) in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control, as assessed by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive ibuprofen orally (PO) twice daily (BID) for 6 weeks.

ARM II: Patients receive placebo PO BID for 6 weeks.

After completion of study, patients are followed up periodically.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups, including a placebo group

Arm I (ibuprofen)

Experimental group

Description:

Patients receive ibuprofen PO BID for 6 weeks.

Treatment:

Drug: Ibuprofen

Other: Questionnaire Administration

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO BID for 6 weeks.

Treatment:

Other: Placebo

Other: Questionnaire Administration