Clinical trial NCT06950190: Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)
Official title: Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chemotherapy-related Cognitive Impairment
Keywords: Cognitive Function
Cancer Survivorship
Cognitive Decline
Neurotoxicity
Chemotherapy
Chemobrain
Quality of Life
Behavioral Oncology
Lead sponsor: Ellis Medicine
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Chemotherapy-related cognitive impairment (CRCI) is a well-documented side effect of cancer treatment, yet its underlying mechanisms remain poorly understood and effective interventions are lacking. Emerging evidence suggests that physical activity may mitigate cognitive decline through improvements in neuroplasticity, cerebral blood flow, and reduction of inflammation-driven neurotoxicity. This study builds on that foundation by integrating both objective and subjective measures of cognitive function to better capture the patient experience. A mixed-effects ANCOVA model will be used to assess treatment effects over time, with additional analyses exploring the relationship between adherence to the exercise regimen and cognitive outcomes. By leveraging a low-cost, accessible intervention and including diverse demographic and psychosocial factors, this trial aims to inform future strategies for managing CRCI and improving long-term quality of life for cancer patients.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cognitive Function as Measured by MoCA Score
timeFrame: Baseline, 6 months, 9 months, and 12 months
Secondary outcomes:
measure: Correlation Between MoCA Scores and Self-Reported Cognitive Difficulties
timeFrame: Baseline, 6 months, 9 months, and 12 months
Other outcomes:
Locations:
city: Schenectady
country: United States
facility: Ellis Medicine/Roswell Park Medical Oncology
state: New York
Study officials:
affiliation: Ellis Medicine/ Roswell Park
name: Tallat Mahmood, MD
role: PRINCIPAL_INVESTIGATOR
References: