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

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ClinicalTrials.gov Identifier: NCT03186638
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michelle Janelsins, University of Rochester NCORP Research Base

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Malignant Neoplasm Drug: Ibuprofen Other: Placebo Other: Questionnaire Administration Phase 2

Detailed Description:

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).

SECONDARY OBJECTIVES:

I. To provide preliminary data on the effect of ibuprofen on alleviating CRCI in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control by objective assessments of cognitive function.

II. To provide preliminary data on the effect of ibuprofen on alleviating CRCI in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control on phone-based cognitive function measures (digit span, word recall, digits backward, CALVT, category fluency; all from Brief Test of Adult Cognition by Telephone [BTACT]).

III. To provide preliminary data on the effect of ibuprofen on alleviating CRCI in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control on serum pro-inflammatory (MCP-1, IL-6, IL-8, TNF-alpha, sTNFR2, sTNFR1, IL-1beta) and anti-inflammatory (sIL-1Ra, IL-10) cytokines/receptors in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months.

IV. To provide preliminary data on the mediating effects of cytokine/receptor concentrations on the CRCI changes due to ibuprofen in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to placebo control.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase II Study of Low-Dose Ibuprofen for Cognitive Problems in Patients With Cancer
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (ibuprofen)
Patients receive ibuprofen PO BID for 6 weeks.
 Drug: Ibuprofen
Given PO
Other Names:
  • (.+ -.)-p-Isobutylhydratropic acid
  • Advil
  • Motrin
  • p-Isobutylhydratropic acid

Other: Questionnaire Administration
Ancillary studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 6 weeks.
 Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Effects of ibuprofen on alleviating chemotherapy-related cognitive impairment [ Time Frame: Up to 41 days post-intervention ]
    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 and Post 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.


Secondary Outcome Measures :
  1. Objective assessments of cognitive functions [ Time Frame: Up to 41 days post intervention ]
    Will be measured by validated neuropsychological assessment of verbal memory, attention, and executive function and paper-based measures respectively.

  2. Phone-based cognitive function [ Time Frame: Up to 41 days post intervention ]
    Analysis of covariance will be used as with the primary aim analyses to assess mean differences between cognitive function assessed by the remaining objective total scores at post-intervention.

  3. Pro and anti-inflammatory cytokines/receptors analysis [ Time Frame: Up to 41 days post intervention ]
    Will assess the effects of the interventions on cytokines, hypothesizing that each intervention will reduce pro-inflammatory cytokines and increase anti-inflammatory cytokines using the same analysis or covariance analysis.

  4. Cytokine concentrations [ Time Frame: Up to 41 days post intervention ]
    Will provide preliminary data on the mediating effects of cytokine concentrations on the chemotherapy-related cognitive impairment changes due to ibuprofen in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to placebo controls on cytokines/receptors. Will use path modeling to estimate indirect (mediation) effects, and bootstrapping to estimate the 95% confidence intervals. Will evaluate whether cytokines mediate the effect of the intervention on cognitive scores. Will involve a separate analysis for each cytokine, using linear models with arm, pre-intervention cognitive score and with/without cytokine post-pre change scores as model predictors. Will attempt to do a structural equation model where the mediator is a latent variable measured by changes in all the cytokines, and the response is a latent variable.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186638


Locations
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Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michelle C Janelsins University of Rochester NCORP Research Base
More Information
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Responsible Party: Michelle Janelsins, Associate Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT03186638    
Other Study ID Numbers: URCC16092
NCI-2017-00790 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC16092 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-16092 ( Other Identifier: DCP )
URCC-16092 ( Other Identifier: CTEP )
R21CA187500 ( U.S. NIH Grant/Contract )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action