Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)

Ellis Medicine

Status and phase: Not yet enrolling; Phase 3

Conditions: Chemotherapy-related Cognitive Impairment

Treatments: Behavioral: Control Group Intervention; Behavioral: Low-Intensity Walking Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06950190

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Low-Intensity Walking Intervention

Experimental group

Description:

Participants in this arm are asked to double their baseline daily step count ( which will be assessed for one week prior to start of chemo) using a pedometer. This low-intensity walking program is implemented alongside standard chemotherapy treatment with the aim of improving cognitive outcomes. Cognitive function is assessed using the MoCA at four time points (baseline and at three follow-up intervals during the study). Study staff provide regular monitoring and encouragement to help participants reach their step goals, making adjustments as needed to ensure safety and adherence.

Treatment:

Behavioral: Low-Intensity Walking Intervention

Standard of Care (Control)

Other group

Description:

Participants in this arm receive standard care during chemotherapy with no additional exercise intervention. They wear a pedometer for baseline step-count tracking but are not instructed to increase their activity beyond normal daily routines. This group serves as a comparison for the walking intervention group while maintaining usual activity levels. MoCA assessments are conducted at the same four scheduled time points (mirroring the experimental arm's schedule) to evaluate cognitive function without the influence of a prescribed exercise program.

Treatment:

Behavioral: Control Group Intervention