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



Status:Recruiting
Conditions:Cancer, Cancer, Cognitive Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:November 2010
End Date:May 2020

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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

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.

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.

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
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Michelle Janelsins, PhD
Phone: 585-276-4656
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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