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Completed

NCT Number: NCT01238120

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

200 mg BID and 8 hours apart

Other names: nonsteroidal anti-inflammatory drug

Home-Based Exercise

Behavioral

A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period

Other names: Exercise for Cancer Patients

Placebo

Drug

200mg BID and 8 hours apart

Other names: Sugar Pill

Primary outcomes

  1. Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm

    Time frame: Baseline and 6 weeks

    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

Secondary outcomes

  1. Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm

    Time frame: Baseline and 6 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2020
First posted
Nov 10, 2010
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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