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

NCT01238120 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 31416K07CA168886
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer-related Cognitive Difficulties

Keywords

Cancer; Cognitive difficulties

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline and 6 weeks

Study Arms (4)

Placebo and Home-Based Exercise

ACTIVE COMPARATOR

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; Drug: Placebo

Ibuprofen 200mg BID, Home-Based Exercise

ACTIVE COMPARATOR

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; Behavioral: Home-Based Exercise

Placebo

PLACEBO COMPARATOR

200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.

Drug: Placebo

Ibuprofen 200 mg BID

ACTIVE COMPARATOR

200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

200 mg BID and 8 hours apart

Also known as: nonsteroidal anti-inflammatory drug

Ibuprofen 200 mg BID; Ibuprofen 200mg BID, Home-Based Exercise

Home-Based Exercise BEHAVIORAL

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

Also known as: Exercise for Cancer Patients

Ibuprofen 200mg BID, Home-Based Exercise; Placebo and Home-Based Exercise

Placebo DRUG

200mg BID and 8 hours apart

Also known as: Sugar Pill

Placebo; Placebo and Home-Based Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Exercise; Sugars

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Carbohydrates

Results Point of Contact

• Title: Michelle C. Janelsins, PhD, MPH
• Organization: University of Rochester Medical Center

Michelle_Janelsins@urmc.rochester.edu

(585) 276-4656

Study Officials

• Michelle C Janelsins, Ph.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: May 5, 2021
• Results First Posted: March 17, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)