Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive difficulty, Zubrod >2, Dysphagia, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special home devices can reduce hospital visits for people with head and neck cancer by monitoring dehydration risk. Participants in one group will use devices such as a blood pressure monitor and weight scale at home, while doctors track the data. Both groups will also complete health-related surveys. This trial may suit those currently receiving radiation treatment for certain types of head and neck cancer and who can use home monitoring devices. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance patient care.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these monitoring devices are safe for use in head and neck cancer patients?

Research has shown that the CYCORE system, which includes tools like blood pressure monitors and weight scales, has been used in other studies with cancer patients. These tools help monitor dehydration risk at home. In one study, patients using CYCORE experienced less severe cancer-related symptoms. This indicates that the devices are not only helpful but also user-friendly. No serious side effects linked to CYCORE have been reported, suggesting the system is safe for monitoring health issues like dehydration in head and neck cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using advanced technology, like CYCORE devices, to better manage dehydration in head and neck cancer patients. Unlike the standard approach, which involves in-person or telephone surveys, this method allows patients to monitor their health at home using devices like blood pressure monitors and weight scales. This could lead to more timely interventions and improve the quality of life for patients by catching dehydration early. Such technology-driven approaches might streamline patient care and make managing symptoms more efficient and personalized.

What evidence suggests that using monitoring devices at home could be effective in preventing dehydration in head and neck cancer patients?

Research has shown that home-based sensors, such as those in the CYCORE system, can detect early signs of dehydration in head and neck cancer patients. In this trial, participants in the CYCORE Group will use these sensors to monitor vital health signs like weight and blood pressure, which indicate dehydration risk. Early findings suggest that this method can quickly identify dehydration risks, potentially reducing hospital visits. By tracking these health signs at home, patients and doctors can act swiftly to prevent dehydration. This approach aims to help patients manage their health more effectively. ^{1 4 6 7 8}

Who Is on the Research Team?

Susan K. Peterson

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain head and neck cancers, who are fluent in English and receiving or scheduled to receive radiation at MD Anderson Cancer Center. It's not for those who've had previous radiation for these cancers, have a performance status >2, only palliative treatment, disabilities affecting scale use, unilateral radiation treatment, cognitive difficulties or dysphagia unrelated to cancer.

Inclusion Criteria

I am currently undergoing or scheduled for radiation treatment for my cancer.

I have been diagnosed with a specific stage of cancer in the head or neck.

I am currently getting radiation treatment for cancer within the MDACC Cancer Network.

Exclusion Criteria

I have a condition that makes it hard for me to stand on a scale.

I am receiving radiation treatment for symptom relief, not to cure my disease.

I spend most of my day in bed or seated and need help with personal care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive primary radiation treatment (RT) for head and neck cancer

6-7 weeks

Weekly clinic visits

Monitoring

Home-based monitoring using CYCORE devices to assess dehydration risk and provide early intervention

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Device Usability Survey
• Health Management Surveys
• Monitoring Devices
• Quality of Life Survey
• Symptoms Surveys

Trial Overview The study tests if using home devices that assess dehydration risk can reduce hospital visits for head and neck cancer patients. One group uses the CYCORE system to monitor hydration at home while also completing health surveys; the other just completes surveys without device monitoring.

How Is the Trial Designed?

Group I: Standard of Care Group Experimental Treatment 3 Interventions

Surveys administered in person or by telephone interview and are audio-recorded.

Group II: CYCORE Group + Standard of Care Experimental Treatment 5 Interventions

Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer). Surveys administered in person or by telephone interview and are audio-recorded.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The OncoWatch 1.0 feasibility study aims to assess whether patients with head and neck cancer can wear an Apple Watch continuously during radiotherapy, with a target of at least 12 hours per day.

This study will collect biometric data, such as heart rate and physical activity, to explore how these metrics change during treatment, potentially providing valuable insights for monitoring patient symptoms and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study. Holländer-Mieritz, C., Vogelius, IR., Kristensen, CA., et al.[2021]

The implementation of the electronic Patient-Reported Outcome Measure (PROM) 'OncoFunction' in head and neck cancer patients showed high feasibility, with 846 patients completing the PROM during 2,833 out of 3,610 visits (78.5%).

The latest version of 'OncoFunction' significantly reduced errors and time required for use, enhancing the efficiency of data collection and improving patient follow-up care by providing a comprehensive view of their health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. Zebralla, V., Müller, J., Wald, T., et al.[2020]

The study involved 29 patients undergoing radiotherapy for head and neck cancer, but only 38% managed to provide step data for at least 80% of their treatment days, indicating challenges in continuous activity monitoring.

Higher daily step counts were associated with a significantly reduced risk of needing a feeding tube and hospitalization, suggesting that physical activity may play a protective role during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Activity Monitoring and Electronic Patient-Reported Outcomes Collection During Radiotherapy for Head and Neck Cancer: A Pilot Study. Ohri, N., Bar-Ad, V., Fernandez, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3881993/

Identifying Early Dehydration Risk With Home-Based Sensors ... Head and neck cancer patients used home-based sensors to capture weight, blood pressure, pulse, and patient-reported outcomes for two 5-day periods during ...

2. clinicaltrial.be clinicaltrial.be/en/details/11609?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Sensor-Assisted Prevention of Dehydration in Head and ... This project assesses the efficacy of a coordinated dehydration prevention program using a system (CYCORE) that links home-based monitoring ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02253238?tab=history&a=7

Record History | ver. 7: 2015-10-15 | NCT02253238 This project assesses the efficacy of a coordinated dehydration prevention program using a system (CYCORE) that links home-based monitoring sensors--that ...

4. ctv.veeva.com ctv.veeva.com/study/sensor-assisted-prevention-of-dehydration-in-head-and-neck-cancer-patients

Sensor-Assisted Prevention of Dehydration in Head and Neck ... CYCORE is a software-based system that enables comprehensive collection, storage and analysis of information related to cancer research and ...

5. ascopubs.org ascopubs.org/doi/10.1200/jco.2016.34.3_suppl.152

Identifying dehydration risk in head and neck cancer ... Methods: Remote, sensor-based monitoring via CYCORE identifies HNC survivors at increased risk for dehydration (i.e., reduced blood pressure and weight, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8861680/

Feasibility of Mobile and Sensor Technology for Remote ... We evaluated CYCORE's feasibility in studies assessing: (1) physical functioning in colorectal cancer (CRC) patients; (2) swallowing exercise adherence in head ...

7. withpower.com withpower.com/trial/phase-dehydration-2014-00ff0

Sensor-Assisted Prevention of Dehydration in Head and Neck ... Trial Overview The study tests if using home devices that assess dehydration risk can reduce hospital visits for head and neck cancer patients. One group uses ...

8. mdanderson.org mdanderson.org/newsroom/self-reporting-may-reduce-symptom-burden-for-head-neck-cancer-radiation-treatment.h00-159224145.html

Self-reporting with sensor and mobile technology may ... At six-to-eight weeks post-therapy, CYCORE participants again reported less severe general and cancer-related symptoms, scoring significantly ...