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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy

Conditions
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Cancer-related Cognitive Difficulties

Intervention / Treatment
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* Drug: Ibuprofen
* Behavioral: Home-Based Exercise
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo and Home-Based Exercise<br>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. | Behavioral: Home-Based Exercise<br>* A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period<br>* Other names: Exercise for Cancer Patients;Drug: Placebo<br>* 200mg BID and 8 hours apart<br>* Other names: Sugar Pill;|
| Active Comparator: Ibuprofen 200mg BID, Home-Based Exercise<br>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. | Drug: Ibuprofen<br>* 200 mg BID and 8 hours apart<br>* Other names: nonsteroidal anti-inflammatory drug;Behavioral: Home-Based Exercise<br>* A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period<br>* Other names: Exercise for Cancer Patients;|
| Placebo Comparator: Placebo<br>200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. | Drug: Placebo<br>* 200mg BID and 8 hours apart<br>* Other names: Sugar Pill;|
| Active Comparator: Ibuprofen 200 mg BID<br>200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. | Drug: Ibuprofen<br>* 200 mg BID and 8 hours apart<br>* Other names: nonsteroidal anti-inflammatory drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | 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 | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | 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 | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Cognitive difficulties