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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer Patients Who Are Undergoing Chemotherapy Treatments and Are Experiencing Cognitive Difficulties.

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Trial Information

A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing 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 an additional 3 cycles of adjuvant chemotherapy or multiple
cycles over a 42-day 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

- Have an allergy to NSAIDs

- 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 diagnosed with a major psychiatric illness within the last 5 years

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Effects of Physical Activity and Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy

Outcome Description:

Exercise and Ibuprofen (combined or alone) will lead to higher memory performances as assessed by the objective CANTAB delayed matching to sample task in cancer patients receiving adjuvant chemotherapy.

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Michelle C Janelsins, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Institutional Review Board

Study ID:

31416

NCT ID:

NCT01238120

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Cancer Patients Who Are Undergoing Chemotherapy Treatments and Are Experiencing Cognitive Difficulties.
  • Cancer
  • Cognitive difficulties

Name

Location

University of RochesterRochester, New York  14642