Phase 2
N=87
Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer
Cognitive Impairment · Malignant Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03186638 ↗Enrolled (actual)
87
Serious AEs
5.8%
Results posted
Apr 2023
Primary outcome: Primary: Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment — 89.98; 91.08; 105.54; 107.75 score on a scale — p=0.7917
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibuprofen (Drug); Placebo (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester NCORP Research Base
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment |
89.98; 91.08; 105.54; 107.75; 14.59; 15.52 | 0.7917 |
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
Data sourced from ClinicalTrials.gov (NCT03186638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.