Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)

Enrolling by invitation · Phase 3

Conditions studied: Chemotherapy-related Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT06950190

Run by

Ellis Medicine

People needed

100

Starts

2025-06-09

Expected to finish

2027-02-20

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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).

You may not qualify if…

• • 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

Where it is running

• Ellis Medicine/Roswell Park Medical Oncology — Schenectady, New York, United States

Full record on ClinicalTrials.gov

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