Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 140
Summary
- Conditions
- Cognitive Impairment
- Malignant Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 Functio...
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). SECONDARY OBJECTIVES: I. To provide preliminary data on the effect of ibuprofen on alleviating CRCI in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months 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 cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months 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 cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months 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 cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months. IV. To provide preliminary data on the mediating effects of cytokine/receptor concentrations on the CRCI changes due to ibuprofen in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months 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.
Tracking Information
- NCT #
- NCT03186638
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Michelle C Janelsins University of Rochester NCORP Research Base
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