The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
NCT ID: NCT01238120
Last Updated: 2021-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2010-11-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Placebo and 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.
Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
Placebo
200mg BID and 8 hours apart
Ibuprofen 200mg BID, 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.
Ibuprofen
200 mg BID and 8 hours apart
Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
Placebo
200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Placebo
200mg BID and 8 hours apart
Ibuprofen 200 mg BID
200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Ibuprofen
200 mg BID and 8 hours apart
Interventions
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Ibuprofen
200 mg BID and 8 hours apart
Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
Placebo
200mg BID and 8 hours apart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Responsible Party
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Michelle Janelsins, PhD, MPH
Associate Professor
Principal Investigators
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Michelle C Janelsins, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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31416
Identifier Type: -
Identifier Source: org_study_id
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