Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)

Conditions

• Chemotherapy-related Cognitive Impairment

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Low-Intensity Walking Intervention — BEHAVIORAL
  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.
• Control Group Intervention — BEHAVIORAL
  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.

Study Details

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 Dates

Start date

Jun 9, 2025

Status verified

Aug 2025

Primary completion

Feb 20, 2027

Completion

Feb 20, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Low-Intensity Walking Intervention
  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.
• Other: Standard of Care (Control)
  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.

Primary Outcome Measure

Change in Cognitive Function as Measured by MoCA Score [ Time Frame: Baseline, 6 months, 9 months, and 12 months ]

Locations (1)

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