Clinical trial NCT01238120: The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
Official title: A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer-related Cognitive Difficulties
Keywords: Cancer
Cognitive difficulties
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2010-11-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Michelle C Janelsins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: