Clinical trial · Interventional
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
NCT03186638CI-TRIAL-00069898completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Impairment | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibuprofen | Drug | Ibuprofen | ALIAS |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (ibuprofen)
- description
- Patients receive ibuprofen PO BID for 6 weeks.
- interventionNames
- Drug: Ibuprofen
- Other: Questionnaire Administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID for 6 weeks.
- interventionNames
- Other: Placebo
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.