A Phase 2 interventional study of Ibuprofen and Placebo in Cognitive Impairment and Malignant Neoplasm, sponsored by University of Rochester NCORP Research Base. Completed at 169 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by University of Rochester NCORP Research Base · Phase 2, Interventional, and Supportive care
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 87 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Rochester NCORP Research Base is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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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
Exclusion Criteria:
Patients receive ibuprofen PO BID for 6 weeks.
Drug: Ibuprofen · Other: Questionnaire Administration
Patients receive placebo PO BID for 6 weeks.
Other: Placebo · Other: Questionnaire Administration
Given PO
Also known as: (.+ -.)-p-Isobutylhydratropic acid, Advil, Motrin, p-Isobutylhydratropic acid
Given PO
Also known as: placebo therapy, PLCB, sham therapy
Ancillary studies
Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment
Will be assessed by the Functional Assessment of Cancer Therapy-Cognitive Function. Means, standard deviations, and 95% confidence intervals will be determined in order to estimate preliminary population variances and effect sizes. These statistical measures will be calculated by group for the Pre(Baseline) and Post(6 Weeks) measures of the Functional Assessment of Cancer Therapy-Cognitive Function scores as well as the change (post-pre) in the scores using the subjects that completed the study (complete case estimation). The complete case estimates will be compared to multiple imputation estimates based on all subjects that completed pre-intervention. An analysis of covariance will be run using Functional Assessment of Cancer Therapy-Cognitive Function post-intervention as the response. Higher scores indicate better function; range is 0 to 148.
Time frame: Up to 41 days post-intervention
| Milestone | Arm I (Ibuprofen) | Arm II (Placebo) |
|---|---|---|
| Started | 45 | 42 |
| Received intervention and completed baseline assessments | 44 | 40 |
| Completed | 37 | 36 |
| Not completed | 8 | 6 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Withdrawn due to medical problem | 3 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
Will be assessed by the Functional Assessment of Cancer Therapy-Cognitive Function. Means, standard deviations, and 95% confidence intervals will be determined in order to estimate preliminary population variances and effect sizes. These statistical measures will be calculated by group for the Pre(Baseline) and Post(6 Weeks) measures of the Functional Assessment of Cancer Therapy-Cognitive Function scores as well as the change (post-pre) in the scores using the subjects that completed the study (complete case estimation). The complete case estimates will be compared to multiple imputation estimates based on all subjects that completed pre-intervention. An analysis of covariance will be run using Functional Assessment of Cancer Therapy-Cognitive Function post-intervention as the response. Higher scores indicate better function; range is 0 to 148.
| score on a scale | Ibuprofen 200 mg BID | Placebo |
|---|---|---|
| Baseline (Pre) | 89.98 ± 27.82 | 91.08 ± 25.98 |
| 6 Weeks (Post) | 105.54 ± 25.44 | 107.75 ± 24.83 |
| Change from Baseline(Post - Pre) | 14.59 ± 22.02 | 15.52 ± 21.43 |
Collected over Adverse events were collected during the study intervention period. Approximately 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibuprofen 200 mg BID | 0/45 (0%) | 2/45 (4.4%) | 15/45 (33.3%) |
| Placebo | 0/42 (0%) | 3/42 (7.1%) | 15/42 (35.7%) |
| Event | Ibuprofen 200 mg BID | Placebo |
|---|---|---|
| Enterocolitis infectiousGastrointestinal disorders | 0/45 | 1/42 |
| Creatinine increasedRenal and urinary disorders | 0/45 | 1/42 |
| Cystitis noninfectiveRenal and urinary disorders | 0/45 | 1/42 |
| Arterial thromboembolismVascular disorders | 0/45 | 1/42 |
| HypotensionVascular disorders | 0/45 | 1/42 |
| DiarrheaGastrointestinal disorders | 1/45 | 0/42 |
| Enterocolitis infectiousInfections and infestations | 1/45 | 0/42 |
| Creatinine increasedInvestigations | 1/45 | 0/42 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/45 | 0/42 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/45 | 0/42 |
| Event | Ibuprofen 200 mg BID | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 1/45 | 4/42 |
| DiarrheaGastrointestinal disorders | 4/45 | 1/42 |
| AnemiaBlood and lymphatic system disorders | 3/45 | 1/42 |
| Abdominal PainGastrointestinal disorders | 3/45 | 1/42 |
| Lymphocyte count decreasedBlood and lymphatic system disorders | 2/45 | 1/42 |
| Sinus tachycardiaCardiac disorders | 2/45 | 0/42 |
| Mucositis oralGastrointestinal disorders | 2/45 | 0/42 |
| FatigueGeneral disorders | 2/45 | 0/42 |
| Neutrophil count decreasedInvestigations | 2/45 | 0/42 |
| White blood cell decreasedInvestigations | 2/45 | 0/42 |
| Age, Continuous(Years) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| Mean | 55.3 ± 12.5 | 54.6 ± 12.8 | 55 ± 12.6 |
| Sex: Female, Male(Participants) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| Female | 37 | 37 | 74 |
| Male | 8 | 5 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 41 | 38 | 79 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 3 | 2 | 5 |
| White | 40 | 37 | 77 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Cancer Type(Participants) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| Breast | 20 | 20 | 40 |
| Colorectal | 14 | 11 | 25 |
| Other | 10 | 11 | 21 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Education Level(Participants) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| Some High School or Less | 1 | 0 | 1 |
| Highschool/GED | 9 | 5 | 14 |
| Less than 4 Year Degree | 9 | 11 | 20 |
| 4 Year Degree | 16 | 12 | 28 |
| Graduate Degree | 9 | 12 | 21 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Cancer Stage(Participants) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| Stage 1 | 7 | 2 | 9 |
| Stage 2 | 8 | 13 | 21 |
| Stage 3 | 16 | 12 | 28 |
| Stage 4 | 10 | 11 | 21 |
| Unknown or Not Reported | 4 | 4 | 8 |
| Chemotherapy(Participants) | Ibuprofen 200mg BID | Placebo | Total |
|---|---|---|---|
| Actively Receiving | 37 | 34 | 71 |
| Not Actively Receiving | 7 | 8 | 15 |
| Unknown or Not Reported | 1 | 0 | 1 |
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University of Rochester NCORP Research Base