Status:
COMPLETED
The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Cancer-related Cognitive Difficulties
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 cog...
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, E...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01238120
Start Date
November 1 2010
End Date
December 1 2020
Last Update
May 5 2021
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642