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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Rochester
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michelle Janelsins, University of Rochester
ClinicalTrials.gov Identifier:
NCT01238120
First received: November 9, 2010
Last updated: June 17, 2016
Last verified: May 2016
  Purpose
A combination of low-does 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.

Condition Intervention Phase
Cancer-related Cognitive Difficulties
Drug: Ibuprofen
Behavioral: Home-Based Exercise
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Memory performance as assessed by computerized cognitive assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 chemotherapy.


Secondary Outcome Measures:
  • Cognitive functioning score as assessed by FACT-COG Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Exercise and Ibuprofen (combined or alone) will lead to higher cognitive functioning score as assessed subjectively by a psychometrically validated instrument (FACT-COG)


Other Outcome Measures:
  • Levels of Inflammatory cytokines and their receptors [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Exercise and ibuprofen (combined or alone) will lead to reduced levels of inflammatory cytokines and their receptors.


Estimated Enrollment: 116
Study Start Date: November 2010
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
Other Name: Exercise for Cancer Patients
Drug: Placebo
200mg BID and 8 hours apart
Other Name: Sugar Pill
Active Comparator: 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.
Drug: Ibuprofen
200 mg BID and 8 hours apart
Other Name: nonsteroidal anti-inflammatory drug
Behavioral: Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
Other Name: Exercise for Cancer Patients
Placebo Comparator: Placebo
200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Drug: Placebo
200mg BID and 8 hours apart
Other Name: Sugar Pill
Active Comparator: Ibuprofen 200 mg BID
200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Drug: Ibuprofen
200 mg BID and 8 hours apart
Other Name: nonsteroidal anti-inflammatory drug

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238120

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Michelle Janelsins, PhD    585-276-4656    michelle_janelsins@urmc.rochester.edu   
Contact: Kassandra Doyle    585-276-7142    kassandra_doyle@urmc.rochester.edu   
Principal Investigator: Michelle Janelsins, PhD         
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michelle C Janelsins, Ph.D. University of Rochester
  More Information

Responsible Party: Michelle Janelsins, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01238120     History of Changes
Other Study ID Numbers: 31416  K07CA168886 
Study First Received: November 9, 2010
Last Updated: June 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Overall study results will be presented to participants, faculty and staff at the University of Rochester Medical Center. tudy results will be presented at professional meetings and published

Keywords provided by University of Rochester:
Cancer
Cognitive difficulties

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016