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

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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 cognitive difficulties among cancer patients receiving chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen

Criteria

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