Low-Intensity Walking for Cognitive Impairment During Chemotherapy

((ECCPC) Trial)

Overseen By Renee B Jahn, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ellis Medicine

Disqualifiers: Dementia, Neurologic disorder, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a simple walking program can improve thinking and memory in cancer patients undergoing chemotherapy. Participants are divided into two groups: one maintains their usual routine, while the other doubles their daily steps using a pedometer as part of the Low-Intensity Walking Intervention. The goal is to determine if walking can reduce "chemo brain," the cognitive decline some experience during chemotherapy. Eligible participants can walk without assistance and will receive chemotherapy for up to 6 months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment validation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that moderate walking can help cancer patients on chemotherapy feel better and think more clearly. In studies, participants who walked regularly reported improved well-being and performed better on cognitive tests. Walking is safe for most people and doesn't cause serious side effects, making it a good option for those wanting to maintain mental sharpness during treatment. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cognitive impairment?

Researchers are excited about the low-intensity walking intervention for cognitive impairment during chemotherapy because it offers a simple, non-drug approach to potentially enhance cognitive function. Unlike traditional treatments that might focus on medications to manage cognitive issues, this intervention encourages patients to double their baseline daily step count, integrating physical activity seamlessly into their daily routine. This method not only aims to improve cognitive outcomes but does so in a way that promotes overall physical well-being without additional medications or invasive procedures.

What evidence suggests that low-intensity walking might be an effective treatment for cognitive impairment during chemotherapy?

Research has shown that moderate walking can improve thinking and memory in cancer patients undergoing chemotherapy. In this trial, participants in the Low-Intensity Walking Intervention arm will double their baseline daily step count using a pedometer, alongside standard chemotherapy treatment. Studies have found that exercise boosts brain function in both healthy older adults and those with memory issues. For instance, a 6-month low-intensity exercise program helped breast cancer patients who had chemotherapy feel better about their cognitive abilities. A review of multiple studies also found that exercise improves brain function in breast cancer patients and survivors. These findings suggest that regular, gentle walking could help maintain brain health during chemotherapy. ^{1 2 6 7 8}

Who Is on the Research Team?

Tallat Mahmood, MD

Principal Investigator

Ellis Medicine/ Roswell Park

Are You a Good Fit for This Trial?

This trial is for adult cancer patients experiencing cognitive issues during chemotherapy. Participants must be able to walk and willing to follow a low-intensity exercise program or maintain their usual activity level. Specific eligibility criteria are not provided, but typically include being medically stable enough to participate.

Inclusion Criteria

Able and willing to provide written informed consent

I have cancer confirmed by a biopsy and will be starting chemotherapy.

I can walk without needing help from devices.

Exclusion Criteria

Patients with a psychiatric diagnosis (other than depression)

Patients with a diagnosis of dementia of any type

Patients with a history of traumatic brain injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants' baseline daily step count is assessed using a pedometer for one week prior to the start of chemotherapy

1 week

1 visit (in-person)

Chemotherapy and Intervention

Participants undergo chemotherapy. The intervention group doubles their baseline daily step count, while the control group maintains usual activity. Cognitive function is assessed using MoCA at baseline, 6, 9, and 12 months.

12 months

4 visits (in-person)

Follow-up

Participants are monitored for cognitive function and self-reported cognitive difficulties using MoCA and questionnaires at 6, 9, and 12 months.

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Control Group Intervention
• Low-Intensity Walking Intervention

Trial Overview The study tests if doubling daily steps with a pedometer can help prevent 'chemo brain', compared to standard care without extra walking. Cognitive function is checked using the MoCA test at several points over a year, alongside self-reported cognitive and psychological assessments.

How Is the Trial Designed?

Group I: Standard of Care (Control) Experimental Treatment 1 Intervention

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.

Group II: Low-Intensity Walking Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Ellis Medicine

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

The EPICC Study is a randomized controlled trial involving 254 postmenopausal women with early-stage breast cancer, testing the impact of a six-month moderate-intensity aerobic exercise program on cognitive function during aromatase inhibitor therapy.

This study aims to address cognitive impairment, which affects up to 75% of breast cancer survivors, and if successful, could establish exercise as a low-cost, adaptable intervention to improve cognitive health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy. Gentry, AL., Erickson, KI., Sereika, SM., et al.[2023]

This study will evaluate the impact of a 3-month physical activity intervention on cognitive functioning in 80 sedentary breast cancer survivors who report cognitive difficulties, comparing results to a waitlist control group.

The research aims to uncover not only changes in neuropsychological outcomes and cognitive concerns but also the biological mechanisms behind these effects by analyzing biomarkers related to brain health and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of increasing physical activity on cognitive functioning in breast cancer survivors: Rationale and study design of Memory & Motion. Hartman, SJ., Natarajan, L., Palmer, BW., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-3-chemotherapy-related-cognitive-impairment-3-2025-a56d0

Low-Intensity Walking for Cognitive Impairment During ... Research suggests that moderate levels of walking can benefit cognitive function and psychosocial well-being in breast cancer patients undergoing chemotherapy, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8559683/

The Effect of Exercise on Cancer-Related Cognitive ... Accumulating evidence demonstrates exercise can improve cognitive function in healthy older adults and adults with cognitive impairments.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06950190/evaluating-cognitive-changes-on-patients-in-chemotherapy-eccpc

Evaluating Cognitive Changes on Patients in ... This randomized clinical trial aims to evaluate the impact of a structured low-intensity exercise program on cognitive function in adult ...

4. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-022-01530-2

Effect of physical exercise on cognitive function after ... A 6-month exercise intervention improved self-reported cognitive functioning, physical fitness, fatigue, QoL, and depression in chemotherapy-exposed breast ...

5. link.springer.com link.springer.com/article/10.1007/s12282-025-01757-9

a systematic review with meta-analysis | Breast Cancer Our results indicate that exercise effectively improves cognitive function in breast cancer patients and survivors, aligning with meta-analyses ...

6. link.springer.com link.springer.com/article/10.1007/s10549-023-07220-7

Effects of physical exercise during adjuvant chemotherapy ... We observed no statistically significant effect of exercise, or being physically active during chemotherapy, on long-term cognitive performance ...

7. frontiersin.org frontiersin.org/journals/cognition/articles/10.3389/fcogn.2023.1289415/full

Exercise during chemotherapy to prevent breast cancer ... Physical activity has emerged as a promising solution for maintaining cognitive health after cancer, with research suggesting that earlier ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10211382/

Effect of Physical Activity During Chemotherapy on Cognitive ... Our study reveals a positive effect of a combined resistance and aerobic exercise intervention on social cognition functioning in survivors undergoing ...