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

Cancer-related Cognitive Difficulties Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238120
• Other study ID #: 31416
• Secondary ID: K07CA168886
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: December 2020

Study information

• Verified date: April 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer-related Cognitive Difficulties

Intervention

Drug:
• Ibuprofen
200 mg BID and 8 hours apart

Behavioral:
• Home-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period

Drug:
• Placebo
200mg BID and 8 hours apart

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm	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	Baseline and 6 weeks
Secondary	Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm	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	Baseline and 6 weeks