NCT03186638

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

Phase II Study of Low-Dose Ibuprofen for Cognitive Problems in Patients With Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: University of Rochester NCORP Research Base · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cognitive Impairment
• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Ibuprofen	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-05-26
• Primary completion: 2022-03-30
• Completion: 2022-06-01
• First posted: 2017-06-14
• Last updated: 2023-09-25
• Results posted: 2023-04-21

Locations

169 sites across 1 country: United States

Regulatory

• FDA-regulated drug study