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Chemotherapy-related Cognitive ImpairmentPhase 3(ECCPC)NCT06950190

Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)

A Phase 3 study testing Low-Intensity Walking Intervention in people with Chemotherapy-related Cognitive Impairment, run by Ellis Medicine at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low-Intensity Walking Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
9 Jun 2025to 20 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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).

Who cannot join

  • • 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.
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Ellis Medicine/Roswell Park Medical Oncology

    Schenectady, New York, 12308

Other trials in United States

About this study

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.

Read the 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.

Being tested
Low-Intensity Walking Intervention, Control Group Intervention
Keywords
Cognitive Function, Cancer Survivorship, Cognitive Decline, Neurotoxicity, Chemotherapy, Chemobrain, Quality of Life, Behavioral Oncology
Medical subject headings
Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction, Neurotoxicity Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-Intensity Walking InterventionBehavioural

    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 InterventionBehavioural

    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 groups in NCT06950190
Study groupRoleWhat they receive
Low-Intensity Walking InterventionExperimentalParticipants 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.
Receives: Behavioral: Low-Intensity Walking Intervention
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.
Receives: Behavioral: Control Group Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 6 months, 9 months, and 12 months

Secondary outcomes (1)

  1. Correlation Between MoCA Scores and Self-Reported Cognitive Difficulties

    This outcome examines how well participants' MoCA scores align with their own self-reported cognitive difficulties. Self-reported data will be collected using a structured questionnaire to capture subjective experiences of memory, attention, and mental clarity. The analysis will assess whether objective cognitive test results reflect participants' perceived impairments.

    Measured: Baseline, 6 months, 9 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start9 Jun 2025
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06950190
Sponsor's protocol ID
0
Acronym
(ECCPC)
Status last verified
Aug 2025
First submitted
22 Apr 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low-Intensity Walking Intervention in people with Chemotherapy-related Cognitive Impairment, run by Ellis Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Function as Measured by MoCA Score (time frame: Baseline, 6 months, 9 months, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06950190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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