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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual exercise program to determine its effectiveness in improving thinking and memory problems in young brain tumor survivors. The program, called the Virtual Home-based Exercise Intervention (RISE), includes aerobic and strength training exercises, which might also influence gut microorganisms, potentially enhancing cognitive function. Participants will either follow this exercise routine or receive regular check-ins and wear a fitness tracker. Those treated with radiation for a brain tumor and who now struggle with focus and memory might be suitable candidates, especially if they currently exercise less than 150 minutes a week. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance cognitive health for brain tumor survivors.

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 prior data suggests that this virtual exercise program is safe for adolescent and young adult brain tumor survivors?

Research shows that exercise programs like RISE are generally safe and can boost brain function. Studies have found that exercise improves mental skills in both healthy individuals and those with memory or thinking problems. No major safety concerns have been reported with online exercise programs, and participants usually handle them well.

Additionally, moderate exercise, such as aerobic and strength training, has been shown to help with focus and memory. This suggests that the RISE program should be safe for participants. It offers personalized exercise plans to fit each person's needs, which helps reduce any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to tackle "chemobrain," which is cognitive impairment after chemotherapy. Unlike traditional treatments that might focus on medication or cognitive therapy, this trial uses a Virtual Home-based Exercise Intervention (RISE) to blend personalized aerobic and strength training with lifestyle coaching, all delivered virtually. This method is groundbreaking because it leverages technology like Physitrack and Fitbits to make exercise accessible and trackable from home, potentially offering a more engaging and convenient option for patients. By integrating exercise into daily life with tailored guidance, the trial aims to improve cognitive function in a way that’s both sustainable and adaptable to individual needs.

What evidence suggests that the Virtual Home-based Exercise Intervention (RISE) is effective for cancer-related cognitive impairment?

Studies have shown that exercise can enhance brain function, improving attention and memory, particularly for individuals facing cognitive challenges from cancer treatment. Research indicates that aerobic and resistance training activities can boost brain function. Specifically, one study found that online exercise programs benefited cancer patients with treatment-related cognitive issues. Additionally, exercise can alter the gut microbiome, potentially further enhancing brain function. In this trial, participants in the RISE program, a virtual home-based exercise intervention, will engage in personalized, progressive aerobic and strength training exercises. These findings suggest that the RISE program could aid brain tumor survivors dealing with cancer-related cognitive impairment (CRCI). ^{1 2 3 5 6}

Who Is on the Research Team?

Jinbing Bai, PhD, RN

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Able to provide informed consent/assent

I am between 15 and 39 years old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00495703

Study Details | NCT00495703 | The Activity Intervention for ... We will employ a proven home-based exercise intervention and state of the art cognitive testing of relevant cognitive domains (e.g., Randt Memory Test, Trail ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10049401/

Effectiveness of a Computerized Home-Based Cognitive ... The current study describes a computerized home-based cognitive stimulation program in patients who survived breast cancer.

3. withpower.com withpower.com/trial/virtual-exercise-for-chemobrain-02b7b

Virtual Exercise for Chemobrain Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may ...

4. 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.

5. curetoday.com curetoday.com/articles/webbased-exercises-may-ease-chemobrain

Web-Based Exercises May Ease Chemobrain Online mental exercises showed an improvement in cognitive function for patients with cancer who were facing treatment-related cognitive impairment, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06686823

NCT06686823 | Effects of a Cognitive Training Program on ... Objective: To assess the effectiveness of a cognitive training program in managing CRCI in individuals with breast cancer undergoing active treatment.