CompletedPhase 2

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

United States110 participantsStarted 2010-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm

Timeframe: Baseline and 6 weeks

Trial details

NCT IDNCT01238120

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Results submitted2020-12-21

View on ClinicalTrials.gov More Cancer-related Cognitive Difficulties trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.