Phase 2
N=97
The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
Cancer-related Cognitive Difficulties
Bottom Line
View on ClinicalTrials.gov: NCT01238120 ↗Enrolled (actual)
97
Serious AEs
4.1%
Results posted
Mar 2021
Primary outcome: Primary: Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm — 75.2; 82.7; 83.6; 74.3 % correct — p=0.9168
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibuprofen (Drug); Home-Based Exercise (Behavioral); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm |
75.2; 82.7; 83.6; 74.3; 89.4; 90.0 | 0.9168 |
| SECONDARY Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm |
74.7; 72.7; 85.9; 76.2; 80.5; 76.5 | 0.6536 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01238120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.