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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cancer-related Cognitive Difficulties

In brief

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.

Key facts

Study ID

NCT01238120

Run by

University of Rochester

People needed

110

Starts

2010-11-01

Expected to finish

2020-12-01

Last updated by the study team

2021-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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