Last updated on May 2019

Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Non-metastatic Colorectal Cancer Receiving Chemotherapy


Brief description of study

This randomized phase II trial studies how well low-dose ibuprofen in improving cognitive impairment in patients with colorectal cancer that has not spread to other places in the body who are receiving chemotherapy. Anti-inflammatory agents, such as ibuprofen, may slow the decline of cognitive processes and diseases involving the brain.

Detailed Study Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To provide preliminary data on the effect of ibuprofen on alleviating CRCI in colorectal cancer patients receiving chemotherapy compared to a placebo control by objective assessments of cognitive function.

II. To provide preliminary data on the effect of ibuprofen on alleviating CRCI in colorectal cancer patients receiving chemotherapy compared to a placebo control on phone-based cognitive function measures (digit span, word recall, digits backward, CALVT, category fluency; all from Brief Test of Adult Cognition by Telephone [BTACT]).

III. To provide preliminary data on the effect of ibuprofen on alleviating CRCI in colorectal cancer patients receiving chemotherapy compared to a placebo control on serum pro-inflammatory (MCP-1, IL-6, IL-8, TNF-alpha, sTNFR2, sTNFR1, IL-1beta) and anti-inflammatory (sIL-1Ra, IL-10) cytokines/receptors in colorectal cancer patients receiving chemotherapy.

IV. To provide preliminary data on the mediating effects of cytokine/receptor concentrations on the CRCI changes due to ibuprofen in colorectal cancer patients receiving chemotherapy compared to placebo control.

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.

Clinical Study Identifier: NCT03186638

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