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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Low-Intensity Walking for Cognitive Impairment During Chemotherapy?

Research suggests that moderate levels of walking can benefit cognitive function and psychosocial well-being in breast cancer patients undergoing chemotherapy, as well as in healthy adults, children, and the elderly. Exercise interventions, including walking, have shown preliminary positive effects on cognitive impairments related to cancer treatment. ^{1 2 3 4 5}

Is low-intensity walking safe for people undergoing chemotherapy?

Research suggests that walking, even at low intensity, is generally safe for people undergoing chemotherapy. Studies have shown that walking can help reduce fatigue, anxiety, and depressive symptoms in patients, indicating it is a safe activity during treatment. ^{1 2 6 7 8}

How does low-intensity walking differ from other treatments for cognitive impairment during chemotherapy?

Low-intensity walking is unique because it is a simple, self-managed physical activity that can be done at home, unlike other treatments that may require supervision or specific settings. It focuses on maintaining cognitive function through gentle exercise, which is accessible and low-cost, making it a practical option for many patients. ^{1 2 3 4 9}

Research Team

Tallat Mahmood, MD

Principal Investigator

Ellis Medicine/ Roswell Park

Eligibility Criteria

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 history of traumatic brain injury

Patients with a diagnosis of dementia of any type

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Patterns and Relationships With Cognitive Function in Patients With Breast Cancer Before, During, and After Chemotherapy in a Prospective, Nationwide Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Exercise Interventions and Physical Activity Behavior on Cancer Related Cognitive Impairments: A Systematic Review. [2022]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A scoping review of studies exploring physical activity and cognition among persons with cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of increasing physical activity on cognitive functioning in breast cancer survivors: Rationale and study design of Memory & Motion. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of a walking intervention on fatigue-related experiences of hospitalized acute myelogenous leukemia patients undergoing chemotherapy: a randomized controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise during chemotherapy: Friend or foe? [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions and physical activity behavior on cancer-related cognitive impairments: an update. [2018]