Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC) (NCT06950190) | Clinical Trial Compass
By InvitationPhase 3
Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)
United States100 participantsStarted 2025-06-09
Plain-language summary
This randomized clinical trial aims to evaluate the impact of a structured low-intensity exercise program on cognitive function in adult cancer patients undergoing chemotherapy. The study enrolls 100 participants who are randomly assigned to either a standard care group or an exercise intervention group. Cognitive function is measured using the Montreal Cognitive Assessment (MoCA) at baseline, 6, 9, and 12 months. Participants in the intervention group are instructed to double their baseline daily step count, tracked via pedometer, while those in the control group maintain their usual activity. All patients are given the pedometer for one week prior to the start of chemo to monitor their step count and determine their baseline. The study also collects self-reported data on cognitive difficulties and psychological well-being. The primary objective is to determine whether regular physical activity mitigates chemotherapy-related cognitive decline ("chemo brain") and whether MoCA scores correlate with patients' subjective experiences. This low-cost, home-based approach may offer an accessible strategy for preserving cognitive function during cancer treatment.
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:
* • Age 18 years and older.
* Patients with histologically confirmed malignancy who are planning on receiving chemotherapy.
* Able and willing to provide written informed consent.
* ECOG performance status less than or equal to 2.
* Patients willing and able to perform the exercise as directed.
* Patients with the ability to walk without use of an assistive device.
* Patients with no underlying psychiatric disorder (other than depression, as long as there has been no acute presentation within 6 months of being enrolled in the study).
Exclusion Criteria:
* • Under the age of 18 years.
* Patients unable to provide informed consent.
* Patients who are non-ambulatory or who have a physical disability preventing exercise.
* ECOG performance status greater than 2.
* Patients with a psychiatric diagnosis (other than depression)
* Patients with a diagnosis of dementia of any type.
* Patients with a neurologic disorder that one could reasonably assume to have an underlying cognitive impairment.
* Patients with a history of traumatic brain injury.
* Patients who will be on chemotherapy for longer than 6 months
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
1
Change in Cognitive Function as Measured by MoCA Score
Timeframe: Baseline, 6 months, 9 months, and 12 months