Apple Watch Monitoring for Glioblastoma

Overseen By Andrew Dhawan, MD, DPhil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Under 18, Language barrier, Tattoos, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the Apple Watch can track symptom changes in people with glioblastoma, a type of brain cancer. Researchers aim to determine if data such as walking patterns, heart rate, breathing, and sleep from the watch can predict changes in participants' well-being before they occur. Participants will wear the watch for at least six months, with the option to continue longer. This trial suits those newly diagnosed or undergoing treatment for glioblastoma who can use an iPhone with the watch and have no tattoos or skin issues on the wrist where the watch is worn. As an unphased trial, it offers a chance to contribute to innovative research using everyday technology to potentially improve symptom management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Apple Watch is safe for monitoring health data?

Research has shown that the Apple Watch is generally safe for health monitoring. Studies have found it can track health data effectively without harming users. For example, one study demonstrated its ability to monitor health in people with epilepsy, proving its practicality for everyday use. No major reports of problems have emerged from wearing the Apple Watch.

Since this trial focuses on collecting data from the watch, not on a new drug or surgery, safety concerns remain minimal. The Apple Watch is already widely used by the public and approved for health monitoring in many situations. This suggests it is well-tolerated and poses a low risk of side effects for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Apple Watch for monitoring glioblastoma because it offers a non-invasive, continuous way to track health data. Unlike traditional treatments like surgery, chemotherapy, or radiation, which focus on directly attacking the tumor, this approach uses wearable technology to gather real-time information on a patient's health. This could potentially lead to earlier detection of changes or complications, allowing for timely medical interventions. Overall, this method could complement existing treatments by providing a more comprehensive picture of how a patient's condition evolves over time.

What evidence suggests that the Apple Watch is effective for monitoring glioblastoma?

Research shows that the Apple Watch can track health information for people with glioblastoma, a type of brain cancer. Studies have found that it accurately monitors heart rate and steps, potentially aiding in detecting health changes. In this trial, participants will wear the Apple Watch to log health data, which could help predict disease progression. By tracking walking, heart rate, and sleep, the watch may identify problems early, making symptom management easier and improving care. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrew Dhawan, MD, DPhil

Principal Investigator

Brain Tumor Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Rowan Barker-Clarke, PhD

Principal Investigator

Lerner Research Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Siamrut Patanavanich

Principal Investigator

Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with glioblastoma, either newly-diagnosed or recurrent, who are undergoing treatment or surveillance. Participants need to understand the consent form, have an iPhone to use with the Apple Watch app, and be physically active enough (KPS ≥ 70%). It's not for those under 18, unable to consent due to language barriers, without an iPhone, having wrist tattoos/skin conditions affecting the watch sensor or unable to wear the watch consistently.

Inclusion Criteria

access to patient or caregiver's own Apple iPhone to interface with watch application for documentation of symptoms

I am mostly able to care for myself and carry out daily activities.

able to comprehend informed consent form and provide informed consent

Exclusion Criteria

I am under 18 years old.

You can't wear an Apple Watch for at least 12 hours a day on at least half of the days in a four-week period.

inability to give informed consent due to aphasia or other language barrier

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Participants wear an Apple Watch to collect continuous actigraphy data and annotate symptom occurrence

6 months

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after the monitoring period

4 weeks

Extension (optional)

Participants may choose to continue participation in the study beyond the initial 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Apple Watch

Trial Overview The study tests if measurements from an Apple Watch—like walking data, heart rate, breathing rate and sleep patterns—can relate to how patients feel during treatment changes. The goal is using this data to predict complications or symptom changes in advance.

How Is the Trial Designed?

Group I: Wearing the Apple watch and the associated logging of health data Experimental Treatment 1 Intervention

As part of the monitoring needed for this study, participants will be enrolled for at least 6 months, as this will give enough data to understand how the participant's health changes associate with what is measured by the Apple watch. After this 6 month period, participants may choose to end their participation on the study, or continue if they wish.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Glioblastoma (GB) is a highly aggressive brain tumor with a poor prognosis, where most patients do not survive beyond one year despite treatment, and the median survival for eligible patients is around 16-17 months.

The standard treatment for GB involves maximal surgical resection followed by radiotherapy and concurrent temozolomide chemotherapy, which has been shown to improve survival rates in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of newly diagnosed malignant glioma in the elderly people: new trials that impact therapy. Chamberlain, MC.[2018]

The study analyzed 952 cases of glioblastoma multiforme (GBM) in France, revealing that median overall survival was 286 days, significantly influenced by factors such as age, performance status, and tumor location.

Patients who underwent surgical resection followed by radiotherapy and temozolomide had the best median survival of 476 days, highlighting the importance of combined treatment strategies in improving outcomes for GBM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological patterns of care and outcome for 952 patients with newly diagnosed glioblastoma in 2004. Bauchet, L., Mathieu-Daudé, H., Fabbro-Peray, P., et al.[2023]

Despite aggressive treatment options for glioblastoma, including surgery and chemotherapy, the median survival remains low at 14-16 months, highlighting the need for new therapeutic strategies.

Recent data suggest that the Optune™ device, which delivers alternating electrical field therapy, may improve survival in newly diagnosed glioblastoma patients, indicating a promising new approach alongside traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What next for newly diagnosed glioblastoma? Domingo-Musibay, E., Galanis, E.[2022]

Histological confirmation remains the gold standard for diagnosing malignant gliomas, with molecular markers like IDH mutation and MGMT promoter methylation providing crucial prognostic information and guiding treatment decisions.

Current treatment for glioblastoma typically involves temozolomide combined with radiotherapy, while ongoing clinical trials are investigating new therapies, including anti-angiogenic agents like bevacizumab and immunotherapy options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel diagnostic and therapeutic approaches to malignant glioma. Weller, M.[2022]

Giant cell glioblastoma (gcGBM) shows distinct genetic characteristics compared to classic IDH-wildtype GBM, including a higher frequency of TP53, ATRX, RB1, and NF1 mutations, and lower rates of EGFR amplification and CDKN2A deletion.

Patients with TP53-mutant gcGBMs have better overall survival rates than those with TP53-wildtype GBMs, suggesting that genetic profiling could inform treatment strategies and highlight the potential for immune checkpoint therapy in cases with high tumor mutation load.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TP53, ATRX alterations, and low tumor mutation load feature IDH-wildtype giant cell glioblastoma despite exceptional ultra-mutated tumors. Cantero, D., Mollejo, M., Sepúlveda, JM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06129760

NCT06129760 | Glioblastoma Remote Monitoring and Care The purpose of this research is to learn more about how what the Apple watch measures, in terms of walking data, heart rate, breathing rate, ...

2. researchgate.net researchgate.net/publication/390613580_Apple_watch_accuracy_in_monitoring_health_metrics_a_systematic_review_and_meta-analysis

(PDF) Apple watch accuracy in monitoring health metrics This study demonstrates that while the Apple Watch generally provides accurate HR and step measurements, its accuracy for EE is limited.

3. withpower.com withpower.com/trial/phase-glioblastoma-3-2024-0837e

Apple Watch Monitoring for Glioblastoma This trial uses the Apple Watch and an iPhone app to monitor glioblastoma patients' health data continuously. The goal is to detect early signs of ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/can-smartwatch-data-predict-progression-and-detect-complications-in-patients-with-glioblastoma

Can Smartwatch Data Help Monitor Patients With Glioblastoma? Cleveland Clinic researchers are harnessing the power of smartwatch data to predict disease progression in patients with glioblastoma.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7821483/

Consumer-grade electroencephalography devices as ... Diffuse gliomas, such as glioblastoma (GBM), represent the most common and aggressive form of brain cancer with an unfortunate dearth of treatment advances ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505024002890

Prospective multicenter study of continuous tonic-clonic ... This study demonstrates the practicability of TCS monitoring on a popular consumer wearable (Apple Watch) in daily use for people with epilepsy.