Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)
(ECCPC)
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2025
CompletedFirst Posted
Study publicly available on registry
April 30, 2025
CompletedStudy Start
First participant enrolled
June 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 20, 2027
August 12, 2025
August 1, 2025
1.7 years
April 22, 2025
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cognitive Function as Measured by MoCA Score
This outcome evaluates whether cognitive decline associated with chemotherapy ("chemo brain") can be measured using the MoCA, a brief and validated tool suitable for clinical settings. The goal is to determine if MoCA can effectively detect changes in cognitive performance over the course of chemotherapy without the need for extensive neuropsychological testing.
Baseline, 6 months, 9 months, and 12 months
Secondary Outcomes (1)
Correlation Between MoCA Scores and Self-Reported Cognitive Difficulties
Baseline, 6 months, 9 months, and 12 months
Study Arms (2)
Low-Intensity Walking Intervention
EXPERIMENTALParticipants 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.
Standard of Care (Control)
OTHERParticipants 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.
Interventions
Participants in the experimental group will be asked to take part in a home-based, walking program. Each participant will receive a pedometer and will be instructed to increase their baseline daily step count by 100%. For example, if a participant typically walks 3,000 steps per day, they will be asked to increase their activity to 6,000 steps per day. Step counts will be regularly monitored, and participants will receive encouragement and support from study staff to help maintain adherence to the walking goals. In addition to the exercise intervention, participants in this group will undergo cognitive testing using the Montreal Cognitive Assessment (MoCA) at four timepoints: baseline, 6 months, 9 months, and 12 months. They will also complete self-reported questionnaires related to cognitive function at these same intervals. This group is designed to evaluate whether increased physical activity can improve or preserve cognitive function in patients undergoing chemotherapy.
Participants in the control group will receive standard care and will not be given any specific exercise instructions. They will be provided with pedometers to track their daily steps, but they will not be asked to increase or change their usual level of physical activity. These participants will continue with their routine activities and cancer care as directed by their treating physicians. Like the intervention group, they will complete the Montreal Cognitive Assessment (MoCA) at baseline, 6 months, 9 months, and 12 months, as well as self-reported questionnaires about cognitive function at each timepoint. This group will serve as a comparator to determine the impact of the walking intervention on cognitive outcomes.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ellis Medicinelead
Study Sites (1)
Ellis Medicine/Roswell Park Medical Oncology
Schenectady, New York, 12308, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tallat Mahmood, MD
Ellis Medicine/ Roswell Park
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncologist
Study Record Dates
First Submitted
April 22, 2025
First Posted
April 30, 2025
Study Start
June 9, 2025
Primary Completion (Estimated)
February 20, 2027
Study Completion (Estimated)
February 20, 2027
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share