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Cognitive ImpairmentPhase 2NCT03186638

Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer

A Phase 2 study testing Ibuprofen and Questionnaire Administration in people with Cognitive Impairment and Malignant Neoplasm, run by University of Rochester NCORP Research Base at 169 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cognitive Impairment, Malignant Neoplasm
What is being tested?
Ibuprofen and Questionnaire Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
169 sitesUnited States
Study dates
26 May 2017to 1 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

169 sites in 1 country.

169 sites in 1 country

United States169 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Mission Hospital Inc-Memorial Campus

    Asheville, North Carolina, 28801

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Oncology and Hematology Care Southeast

    Clackamas, Oregon, 97015

  • Greenville Health System Cancer Institute-Laurens

    Clinton, South Carolina, 29325

  • Marietta Memorial Hospital

    Columbus, Ohio, 43215

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Medical Center-Edmonds

    Edmonds, Washington, 98026

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • 21st Century Oncology-Henderson

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Desert West Surgery

    Las Vegas, Nevada, 89102

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • OptumCare Cancer Care at Oakey

    Las Vegas, Nevada, 89106

  • 21st Century Oncology

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

  • 21st Century Oncology-Vegas Tenaya

    Las Vegas, Nevada, 89128

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • 21st Century Oncology-Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • University Cancer Center

    Las Vegas, Nevada, 89169

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Fairview Maple Grove Medical Center

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Saint Luke's Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Saint Luke's Mountain States Tumor Institute - Nampa

    Nampa, Idaho, 83686

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware, 19713

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Lakeland Hospital Niles

    Niles, Michigan, 49120

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Hope Cancer Care of Nevada-Pahrump

    Pahrump, Nevada, 89048

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

  • Radiation Oncology Associates

    Reno, Nevada, 89509

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Lakeland Medical Center Saint Joseph

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Nanticoke Memorial Hospital

    Seaford, Delaware, 19973

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Rockwood Cancer Treatment Center-DHEC-Downtown

    Spokane, Washington, 99204

  • Rockwood North Cancer Treatment Center

    Spokane, Washington, 99218

  • Rockwood Clinic Cancer Treatment Center-Valley

    Spokane Valley, Washington, 99216

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • Cancer Care Specialists of Illinois-Swansea

    Swansea, Illinois, 62226

  • Southwest Illinois Health Services LLP

    Swansea, Illinois, 62226

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Saint Luke's Mountain States Tumor Institute-Twin Falls

    Twin Falls, Idaho, 83301

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

  • Providence Regional Cancer System-Yelm

    Yelm, Washington, 98597

Other trials in United States

About this study

Official title: Phase II Study of Low-Dose Ibuprofen for Cognitive Problems in Patients With Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Ibuprofen, Placebo, Questionnaire Administration
Medical subject headings
Cognitive Dysfunction, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbuprofenDrug

    Also called (.+ -.)-p-Isobutylhydratropic acid, Advil, Motrin, p-Isobutylhydratropic acid

    Given PO

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03186638
Study groupRoleWhat they receive
Arm I (ibuprofen)ExperimentalPatients receive ibuprofen PO BID for 6 weeks.
Receives: Drug: Ibuprofen; Other: Questionnaire Administration
Arm II (placebo)Placebo comparatorPatients receive placebo PO BID for 6 weeks.
Receives: Other: Placebo; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 41 days post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start26 May 2017
  3. Primary completion30 Mar 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03186638
Sponsor's protocol ID
URCC16092
Other IDs
NCI-2017-00790, URCC16092, URCC-16092, URCC-16092, R21CA187500, UG1CA189961
Status last verified
Sep 2023
First submitted
7 Jun 2017
Last updated
25 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibuprofen and Questionnaire Administration in people with Cognitive Impairment and Malignant Neoplasm, run by University of Rochester NCORP Research Base at 169 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment (time frame: Up to 41 days post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03186638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.

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