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

Trial Summary

Will I have to stop taking my current medications?

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

How does the Apple Watch Monitoring treatment differ from other glioblastoma treatments?

The Apple Watch Monitoring treatment for glioblastoma is unique because it involves using a wearable device to monitor the condition, which is different from traditional treatments like surgery, chemotherapy, and radiotherapy. This approach may offer a non-invasive way to track the disease, potentially providing real-time data and insights that could complement existing therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

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 complications by analyzing patterns in heart rate, breathing, movement, and sleep. This could help predict problems before they happen. The Apple Watch has been increasingly integrated into health care for monitoring heart rate and other health metrics, with studies suggesting its potential usefulness in detecting conditions like atrial fibrillation and monitoring cardiac health.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

What next for newly diagnosed glioblastoma? [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. India pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Oncological patterns of care and outcome for 952 patients with newly diagnosed glioblastoma in 2004. [2023]

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

TP53, ATRX alterations, and low tumor mutation load feature IDH-wildtype giant cell glioblastoma despite exceptional ultra-mutated tumors. [2022]