Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started May 2017

Longer than P75 for phase_2

Geographic Reach

1 country

169 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

Study Start

First participant enrolled

May 26, 2017

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2017

Completed

7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed

11 months until next milestone

Results Posted

Study results publicly available

April 21, 2023

Completed

Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

4.8 years

First QC Date

June 7, 2017

Results QC Date

March 31, 2023

Last Update Submit

September 13, 2023

Conditions

Cognitive Impairment Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

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.
Up to 41 days post-intervention

Study Arms (2)

Arm I (ibuprofen)

EXPERIMENTAL

Patients receive ibuprofen PO BID for 6 weeks.

Drug: IbuprofenOther: Questionnaire Administration

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID for 6 weeks.

Other: PlaceboOther: Questionnaire Administration

Interventions

IbuprofenDRUG

Given PO

Also known as: (.+ -.)-p-Isobutylhydratropic acid, Advil, Motrin, p-Isobutylhydratropic acid

Arm I (ibuprofen)

PlaceboOTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Questionnaire AdministrationOTHER

Ancillary studies

Arm I (ibuprofen)Arm II (placebo)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Rochester NCORP Research Baselead
National Cancer Institute (NCI)collaborator

Study Sites (169)

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Regional Hematology and Oncology PA

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

Nanticoke Memorial Hospital

Seaford, Delaware, 19973, United States

Location

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

Location

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, 83619, United States

Location

Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Luke's Mountain States Tumor Institute - Nampa

Nampa, Idaho, 83686, United States

Location

Saint Luke's Mountain States Tumor Institute-Twin Falls

Twin Falls, Idaho, 83301, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

SIH Cancer Institute

Carterville, Illinois, 62918, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, 62226, United States

Location

Southwest Illinois Health Services LLP

Swansea, Illinois, 62226, United States

Location

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

Location

Mercy Health Saint Mary's

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49048, United States

Location

Mercy Health Mercy Campus

Muskegon, Michigan, 49444, United States

Location

Lakeland Hospital Niles

Niles, Michigan, 49120, United States

Location

Spectrum Health Reed City Hospital

Reed City, Michigan, 49677, United States

Location

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, 49085, United States

Location

Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview-Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Fairview Maple Grove Medical Center

Maple Grove, Minnesota, 55369, United States

Location

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Health Partners Inc

Minneapolis, Minnesota, 55454, United States

Location

Monticello Cancer Center

Monticello, Minnesota, 55362, United States

Location

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

Location

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

Location

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092, United States

Location

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, 63628, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Capital Region Southwest Campus

Jefferson City, Missouri, 65109, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Carson Tahoe Regional Medical Center

Carson City, Nevada, 89703, United States

Location

Cancer and Blood Specialists-Henderson

Henderson, Nevada, 89052, United States

Location

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States

Location

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, 89052, United States

Location

Las Vegas Cancer Center-Henderson

Henderson, Nevada, 89052, United States

Location

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052, United States

Location

21st Century Oncology-Henderson

Henderson, Nevada, 89074, United States

Location

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, 89074, United States

Location

Desert West Surgery

Las Vegas, Nevada, 89102, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Hope Cancer Care of Nevada

Las Vegas, Nevada, 89103, United States

Location

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, 89106, United States

Location

OptumCare Cancer Care at Oakey

Las Vegas, Nevada, 89106, United States

Location

21st Century Oncology

Las Vegas, Nevada, 89109, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, 89109, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, 89113, United States

Location

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, 89119, United States

Location

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, 89121, United States

Location

21st Century Oncology-Vegas Tenaya