The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients

April 13, 2021 updated by: Michelle Janelsins, PhD, MPH, University of Rochester

A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy

This research seeks to determine if a combination of low-dose ibuprofen along with a structured home-based walking and progressive resistance exercise program, EXCAP, will be effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To conduct a feasibility pilot to assess preliminary efficacy of a 6 week course of ibuprofen (200 mg BID with does 8 hours apart) and a structured home based walking/progressive resistance program, EXCAP, alone or together, on cognitive function and levels of inflammatory molecules among cancer patients receiving chemotherapy (beginning at cycle 2). If these interventions prove to be useful and have potential benefit, they could have a substantial impact on treating cognitive difficulties experienced by cancer patients as well as improve quality of life. Moreover, if there is an effect of these interventions on cognitive functioning and inflammation, we will gain more knowledge of a possible mechanism of chemotherapy-related cognitive difficulties.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must report cognitive difficulties of 3 or higher on a 0-10 scale
  • Must provide informed consent
  • Be able to read English
  • Have a primary diagnosis of cancer
  • Be able to swallow medication
  • Women of child-bearing potential must not be pregnant or become pregnant during the 6 week study
  • Agree not to take NSAIDs during the 6 week intervention period
  • Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over the 42-day study period.
  • Must have the approval of their treating physician to begin the exercise program and receive the ibuprofen
  • Must be over 18 years of age

Exclusion Criteria:

  • Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3 months that is over 400mg daily
  • Have an allergy to ibuprofen
  • Be identified as in active or maintenance stage of exercise behavior as assessed by the single-item exercise stages of change short form
  • have physical limitations that contraindicate participation in sub-maximal physiological fitness testing or a low to moderate home-based walking and progressive resistance program
  • have a history of peptic ulcer disease within the last 12 months
  • Diagnosed with a neurodegenerative disease
  • Had a myocardial infraction within the past 6 months
  • Patients with a neutropenic episode during the first cycle of chemotherapy or at high risk for a neutropenic episode during future chemotherapy cycles at the treating physicians discretion
  • Have confirmed metastatic disease to the central nervous system
  • Have been hospitalized for a major psychiatric illness within the last 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo and Home-Based Exercise
200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.
Behavioral: Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
Other Names:
  • Exercise for Cancer Patients
Drug: Placebo
200mg BID and 8 hours apart
Other Names:
  • Sugar Pill
Active Comparator: Ibuprofen 200mg BID, Home-Based Exercise
200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.
Behavioral: Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
Other Names:
  • Exercise for Cancer Patients
Drug: Ibuprofen
200 mg BID and 8 hours apart
Other Names:
  • nonsteroidal anti-inflammatory drug
Placebo Comparator: Placebo
200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Drug: Placebo
200mg BID and 8 hours apart
Other Names:
  • Sugar Pill
Active Comparator: Ibuprofen 200 mg BID
200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Drug: Ibuprofen
200 mg BID and 8 hours apart
Other Names:
  • nonsteroidal anti-inflammatory drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm
Time Frame: Baseline and 6 weeks
Memory performances (percent correct across delays) as assessed by the objective CANTAB delayed matching to sample task Percentage correct range (0 to 100) Higher percentage is better
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm
Time Frame: Baseline and 6 weeks
Cognitive functioning score as assessed subjectively by a psychometrically validated instrument (FACT-COG) - Perceived Cognitive Impairment (PCI) (min=0, max=116) Higher Score is better
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31416
  • K07CA168886 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Overall study results will be presented to participants, faculty and staff at the University of Rochester Medical Center. tudy results will be presented at professional meetings and published

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer-related Cognitive Difficulties

Clinical Trials on Home-Based Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe