The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
This study is currently recruiting participants.
Verified January 2013 by University of Rochester
Sponsor:
University of Rochester
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01238120
First received: November 9, 2010
Last updated: January 31, 2013
Last verified: January 2013
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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 Feasibility and Acceptability 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: | 40 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | May 2013 (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
|
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, with no distant metastasis or recurrent disease at presentation
- 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
Contacts and Locations
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: Nikki Murray, MS 585-276-4638 nicole_murray@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: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rochester:
|
Cancer Cognitive difficulties |
Additional relevant MeSH terms:
|
Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013