Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01238120
First received: November 9, 2010
Last updated: May 29, 2014
Last verified: May 2014
  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 Patients Who Are Undergoing Chemotherapy Treatments and Are Experiencing Cognitive Difficulties.
Drug: Ibuprofen
Behavioral: Home-Based Exercise (EXCAP)
Drug: Placebo (sugar pill)
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:
  • Effects of Physical Activity and Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy [ 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 adjuvant chemotherapy.


Secondary Outcome Measures:
  • Effects of Physical Activity and Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy [ 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)


Estimated Enrollment: 116
Study Start Date: November 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo and Home-Based Exercise (EXCAP)
Patients will be given 200mg placebo to be taken BID and 8 hours apart beginning on Day 1 of the first on-study chemotherapy cycle for a period of 6 weeks along with a progressive walking and resistance band exercise treatment for a period of 6 weeks.
Behavioral: Home-Based Exercise (EXCAP)
A progressive walking and resistance band exercise program for a 6 week period
Drug: Placebo (sugar pill)
200mg BID and 8 hours apart
Active Comparator: Ibuprofen 200 mg BID and Home-Based Exercise (EXCAP)
Patients will be given 200mg of ibuprofen to be taken BID along with a progressive walking and resistance band exercise treatment beginning on Day 1 of the first on-study chemotherapy for a period of 6 weeks.
Drug: Ibuprofen
200 mg BID and 8 hours apart
Behavioral: Home-Based Exercise (EXCAP)
A progressive walking and resistance band exercise program for a 6 week period
Placebo Comparator: Placebo, sugar pill
Patients will be given a 200mg placebo to be taken BID and 8 hours apart, beginning on Day 1 of the first on-study chemotherapy cycle for a period of 6 weeks.
Drug: Placebo (sugar pill)
200mg BID and 8 hours apart
Active Comparator: Ibuprofen 200 mg BID
Patients will be given 200mg of ibuprofen to be taken BID and 8 hours apart, beginning on Day 1 of the first on-study chemotherapy cycle for a period of 6 weeks.
Drug: Ibuprofen
200 mg BID and 8 hours apart

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
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 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
  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: Alex Skwirz, MS    585-276-7142    alex_skwirz@urmc.rochester.edu   
Principal Investigator: Michelle Janelsins, PhD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Michelle C Janelsins, Ph.D. University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01238120     History of Changes
Other Study ID Numbers: 31416
Study First Received: November 9, 2010
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Cancer
Cognitive difficulties

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

ClinicalTrials.gov processed this record on November 25, 2014