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

Phase 2

Completed

Interventions: Behavioral: Home-Based Exercise
Drug: Ibuprofen
Drug: Placebo

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 cognitive difficulties among cancer patients receiving chemotherapy.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo and Home-Based Exercise	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.
Placebo and Home-Based Exercise	Placebo	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.
Ibuprofen 200mg BID, Home-Based Exercise	Ibuprofen	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.
Ibuprofen 200mg BID, Home-Based Exercise	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.
Placebo	Placebo	200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Ibuprofen 200 mg BID	Ibuprofen	200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.

Primary Outcome Measures

Name	Time	Method
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm	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

Secondary Outcome Measures

Name	Time	Method
Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm	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