Virtual Exercise for Chemobrain

Overseen By Jinbing Bai, PhD, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Secondary malignancies, Traumatic brain injury, Developmental disorders, others

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

Compensation: Varies

Number of Visits: 21

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Virtual Home-based Exercise Intervention (RISE) for chemobrain?

Research shows that exercise, including aerobic activities, can help improve cognitive function in breast cancer patients experiencing cognitive decline due to treatment. Studies have found that exercise may reduce cognitive impairments and improve quality of life, suggesting that a virtual exercise program like RISE could be beneficial. ^{1 2 3 4 5}

Is virtual exercise safe for managing chemobrain?

Exercise, including virtual exercise, is generally considered safe for cancer patients and can help manage treatment-related side effects like cognitive impairment. Studies suggest that various forms of exercise, such as walking, cycling, and yoga, are safe and beneficial for improving cognitive function and managing other toxicities from cancer treatment. ^{1 2 3 5 6}

How is the Virtual Home-based Exercise Intervention (RISE) treatment different from other treatments for chemobrain?

The Virtual Home-based Exercise Intervention (RISE) is unique because it offers a home-based exercise program specifically designed to address cognitive impairments related to chemotherapy, known as chemobrain. Unlike other treatments, RISE leverages virtual technology to provide a structured exercise regimen that can be easily followed at home, potentially improving cognitive function without the need for in-person sessions. ^{1 2 3 7 8}

Research Team

Jinbing Bai, PhD, RN

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adolescent and young adult brain tumor survivors who experience cognitive issues like trouble with attention and memory. Participants should be interested in a virtual exercise program to potentially improve these symptoms.

Inclusion Criteria

I had brain radiation therapy between 6 months and 4 years ago.

I am between 15 and 39 years old.

Able to provide informed consent/assent

Exclusion Criteria

I have a genetic condition or a second cancer, or need more brain radiation.

I have a brain injury that is more severe than what my brain tumor and its treatment would cause.

Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RISE intervention, including aerobic and strength training exercises, and lifestyle behavior coaching for 12 weeks

12 weeks

3-5 virtual exercise sessions per week, 1-2 virtual coaching sessions per week

Follow-up

Participants are monitored for changes in cognitive impairment, physical activity, and gut microbiome

6 weeks

Follow-up assessment at week 18

Treatment Details

Interventions

• Virtual Home-based Exercise Intervention (RISE)

Trial Overview The RISE program, a home-based virtual exercise intervention, is being tested to see if it can help with cancer-related cognitive impairment and alter the gut microbiome in young brain tumor survivors.

Participant Groups

Group I: Arm I (RISE) Experimental Treatment 5 Interventions

Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.

Group II: Arm II (attention control) Active Control 3 Interventions

Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

A 6-month exercise program significantly improved self-reported cognitive functioning, physical fitness, fatigue, quality of life, and depression in breast cancer patients who experienced cognitive problems after chemotherapy, involving 181 participants.

While the exercise did not show a significant effect on overall tested cognitive functioning, it did benefit highly fatigued patients, suggesting that exercise may help improve cognitive issues in this specific subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: a randomized controlled trial (PAM study). Koevoets, EW., Schagen, SB., de Ruiter, MB., et al.[2022]

The GO-EXCAP intervention, which combines a mobile app with a home-based exercise program, was found to be feasible and usable for older patients (average age 72) with myeloid neoplasms undergoing outpatient chemotherapy, with an 88% retention rate and 82% of patients logging exercise data.

Patients increased their average daily steps from 2848 to 3184 and engaged in resistance exercises for about 26.2 minutes per day, indicating that the program effectively encouraged physical activity despite the challenges older patients face in adhering to exercise regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. Loh, KP., Sanapala, C., Watson, EE., et al.[2022]

A study involving 230 breast cancer patients undergoing adjuvant chemotherapy found that both the low-intensity home-based program (Onco-Move) and the moderate- to high-intensity supervised program (OnTrack) significantly reduced declines in cardiorespiratory fitness and improved physical functioning compared to usual care.

The OnTrack program was particularly effective, leading to better muscle strength, reduced physical fatigue, and fewer chemotherapy dose adjustments, while both intervention groups allowed participants to return to work sooner and for more hours than the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-Intensity Physical Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion Rates: Results of the PACES Randomized Clinical Trial. van Waart, H., Stuiver, MM., van Harten, WH., et al.[2022]

References

1. 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]

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

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

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Response Effects of Acute Aerobic Exercise Duration on Cognitive Function in Patients With Breast Cancer: A Randomized Crossover Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: a randomized controlled trial (PAM study). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Exercise for Toxicity Management in Cancer-A Narrative Review. [2020]

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

A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. [2022]

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

Effect of Low-Intensity Physical Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion Rates: Results of the PACES Randomized Clinical Trial. [2022]