Head and Neck CancerNCT02253238
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients
A study testing Quality of Life Survey, Health Management Surveys and Monitoring Devices in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn if home-use of devices to identify dehydration risk, when added to standard care, will help to lower hospitalizations and emergency room visits (and related costs) in patients with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Quality of Life Survey, Health Management Surveys and Monitoring Devices
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2014to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of any of the following cancers: stage 1-4b (includes 4a) oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b (includes 4a) laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; any thyroid cancer that will be addressed with treatment to the bilateral necks; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating MDs
- Currently receiving (or scheduled to receive) radiation treatment for a cancer listed in the inclusion criteria
- Age 18 years or older
- Fluent in English
- Radiation treatment for this cancer was completed (or will be completed) at MD Anderson Cancer Center (Post-RT study only)
- Receiving radiation treatment for this cancer at any site within the MDACC Cancer Network (Cancer Network study only)
Who cannot join
- Overt cognitive difficulty demonstrated by not being clearly oriented to person or place or time
- Zubrod Performance Status >2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care
- History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)
- Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale
- Scheduled to receive or receiving unilateral radiation treatment for this cancer
- Received previous radiation treatment for head and neck cancer
- Consented to enroll in a trial with a toxicity endpoint
- Undergoing only palliative (not curative) radiation treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn if home-use of devices to identify dehydration risk, when added to standard care, will help to lower hospitalizations and emergency room visits (and related costs) in patients with head and neck cancer.
CYCORE is a software-based system that enables comprehensive collection, storage and analysis of information related to cancer research and clinical care. In this study, those in the CYCORE group use devices at home to measure their dehydration risk. This information is monitored by their clinicians. Those in the standard care group complete health based surveys, as do those in the CYCORE group.
Read the detailed description
Abstract:
While head and neck cancer (HNC) is highly curable, primary radiation treatment (RT) is nonetheless challenging. Despite intensive, high-quality, multidisciplinary symptom management of HNC patients during RT, up to 80% of these patients experience moderate to severe levels of oral mucositis making it nearly impossible to drink sufficient fluids and necessitating opioid care for pain. Our data show that 27 - 32% of HNC patients are admitted to inpatient or emergency room (ER) units during RT. Those admissions related to dehydration (and the accompanying costs) are largely preventable, provided at-risk patients can be identified early for intravenous fluid rehydration. Currently, given standard of care for HNC patients undergoing RT, clinicians assess patients only once per week during standard clinic visits. However, the physiological changes underlying the onset of dehydration can develop rapidly, often between clinic visits. In the proposed project, we focus on this missed opportunity for prevention by testing the efficacy of a novel method for home-based dehydration assessment and early intervention to reduce dehydration risk.
This project assesses the efficacy of a coordinated dehydration prevention program using a system (CYCORE) that links home-based monitoring sensors--that collect biometric and self-reported symptom data--to a cyber-infrastructure (CI) and sends these data daily to the patient's healthcare team, who in turn monitor the patients for early signs of dehydration and provide earlier clinical intervention, when needed. The project is based on our successful pilot study that evaluated the feasibility of CYCORE use in HNC patients and with their radiology healthcare team. The patients reported high acceptability of the system, while clinicians perceived the data as valuable and useful in providing additional information regarding patient's at-home dehydration status. We will randomize a total of 192 HNC patients receiving RT at MD Anderson Cancer Center (MDACC) to either standard care or CYCORE + standard care (CYCORE). We hypothesize that patients randomized to CYCORE will experience fewer hospitalizations and ER admissions (and fewer associated costs) due to dehydration compared with patients in the standard care arm.
To the best of our knowledge, the application of a system such as CYCORE has not been explored in the HNC population. Objective, home-based monitoring may be an optimal method of capturing data critical to early evaluation of dehydration risk; other methods, such as patient self-report, are limited by the patient's ability to accurately recall symptoms. MDACC is an ideal environment for conducting the proposed study; more HNC patients are treated with RT at MDACC compared with any other center in Texas, and it is possible to track outcomes and cost-related data, given the HNC patients receive all of their RT-related care, including related hospitalization and ER admissions, at one center. If our efficacy study proves successful, this dehydration prevention model can potentially be applied to other health conditions and in other settings.
- Conditions
- Head and Neck Cancer
- Being tested
- Quality of Life Survey, Health Management Surveys, Monitoring Devices, Symptoms Surveys, Device Usability Survey
- Keywords
- Head and Neck Cancer, Dehydration, Sensor-based home monitoring, Radiation therapy, RT, XRT, Oropharyngeal cancer, Hypopharyngeal cancer, Nasopharyngeal cancer, Salivary gland cancer, Oral cavity cancer, Questionnaires, Surveys, Quality of life, QOL, Phone calls, Self-monitoring devices, CYberinfrastructure for COmparative effectiveness REsearch, CYCORE, Emergency room visits
- Medical subject headings
- Head and Neck Neoplasms, Dehydration, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Nasopharyngeal Neoplasms, Salivary Gland Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life SurveyBehavioural
Also called Survey
Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT.
Health Management SurveysBehavioural
Also called Questionnaires
Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.
Monitoring DevicesOther
Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer)
Symptoms SurveysBehavioural
Behavioral: Symptoms survey 1; completed at weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.
Behaviorial: Symptoms survey 2; completed at baseline, weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.
Device Usability SurveyBehavioural
Also called Questionnaire
Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Other | Surveys administered in person or by telephone interview and are audio-recorded. Receives: Behavioral: Quality of Life Survey; Behavioral: Health Management Surveys; Behavioral: Symptoms Surveys |
| CYCORE Group + Standard of Care | Experimental | 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. Receives: Behavioral: Quality of Life Survey; Behavioral: Health Management Surveys; Other: Monitoring Devices; Behavioral: Symptoms Surveys; Behavioral: Device Usability Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Between the Two Groups of the Number of Hospitalizations and ER Visits Due to Dehydration
Primary outcome is proportion of patients who experience ER visits and/or hospitalizations related to dehydration (ERV) combined with ER visits resulting in hospitalization through the 6-7 weeks of RT. Primary analysis is comparison of proportion of patients in CYCORE group who have an ERV or ERHV and proportion of patients in the standard care group who have an ERV or ERHV. Analysis consists of a binomial test of two proportions using a continuity-corrected chi-square test. Analyses will follow the intention-to-treat principle, that is a patient in either arm who drops out is assumed to have an ERV and/or ERHV. For comparison purposes, data will be analyzed only using patients who have completed the study.
Measured: 12 - 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study start7 Jan 2014
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan K. Peterson, PHD, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253238
- Sponsor's protocol ID
- 2013-0535
- Other IDs
- 1R01CA177914-01, NCI-2015-00946
- Status last verified
- May 2026
- First submitted
- 25 Sep 2014
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT02253238
- Acronym / sponsor ID
- 2013-0535
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Dehydration, Sensor-based home monitoring, Radiation therapy, RT, XRT, Oropharyngeal cancer, Hypopharyngeal cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 427 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jan 2014 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to learn if home-use of devices to identify dehydration risk, when added to standard care, will help to lower hospitalizations and emergency room visits (and related costs) in patients with head and neck cancer.
CYCORE is a software-based system that enables comprehensive collection, storage and analysis of information related to cancer research and clinical care. In this study, those in the CYCORE group use devices at home to measure their dehydration risk. This information is monitored by their clinicians. Those in the standard care group complete health based surveys, as do those in the CYCORE group.
Detailed description
Abstract:
While head and neck cancer (HNC) is highly curable, primary radiation treatment (RT) is nonetheless challenging. Despite intensive, high-quality, multidisciplinary symptom management of HNC patients during RT, up to 80% of these patients experience moderate to severe levels of oral mucositis making it nearly impossible to drink sufficient fluids and necessitating opioid care for pain. Our data show that 27 - 32% of HNC patients are admitted to inpatient or emergency room (ER) units during RT. Those admissions related to dehydration (and the accompanying costs) are largely preventable, provided at-risk patients can be identified early for intravenous fluid rehydration. Currently, given standard of care for HNC patients undergoing RT, clinicians assess patients only once per week during standard clinic visits. However, the physiological changes underlying the onset of dehydration can develop rapidly, often between clinic visits. In the proposed project, we focus on this missed opportunity for prevention by testing the efficacy of a novel method for home-based dehydration assessment and early intervention to reduce dehydration risk.
This project assesses the efficacy of a coordinated dehydration prevention program using a system (CYCORE) that links home-based monitoring sensors--that collect biometric and self-reported symptom data--to a cyber-infrastructure (CI) and sends these data daily to the patient's healthcare team, who in turn monitor the patients for early signs of dehydration and provide earlier clinical intervention, when needed. The project is based on our successful pilot study that evaluated the feasibility of CYCORE use in HNC patients and with their radiology healthcare team. The patients reported high acceptability of the system, while clinicians perceived the data as valuable and useful in providing additional information regarding patient's at-home dehydration status. We will randomize a total of 192 HNC patients receiving RT at MD Anderson Cancer Center (MDACC) to either standard care or CYCORE + standard care (CYCORE). We hypothesize that patients randomized to CYCORE will experience fewer hospitalizations and ER admissions (and fewer associated costs) due to dehydration compared with patients in the standard care arm.
To the best of our knowledge, the application of a system such as CYCORE has not been explored in the HNC population. Objective, home-based monitoring may be an optimal method of capturing data critical to early evaluation of dehydration risk; other methods, such as patient self-report, are limited by the patient's ability to accurately recall symptoms. MDACC is an ideal environment for conducting the proposed study; more HNC patients are treated with RT at MDACC compared with any other center in Texas, and it is possible to track outcomes and cost-related data, given the HNC patients receive all of their RT-related care, including related hospitalization and ER admissions, at one center. If our efficacy study proves successful, this dehydration prevention model can potentially be applied to other health conditions and in other settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | Other | Behavioral: Quality of Life Survey, Behavioral: Health Management Surveys, Behavioral: Symptoms SurveysSurveys administered in person or by telephone interview and are audio-recorded. |
| CYCORE Group + Standard of Care | Experimental | Behavioral: Quality of Life Survey, Behavioral: Health Management Surveys, Other: Monitoring Devices, Behavioral: Symptoms Surveys, Behavioral: Device Usability SurveyHome 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of any of the following cancers: stage 1-4b (includes 4a) oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b (includes 4a) laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; any thyroid cancer that will be addressed with treatment to the bilateral necks; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating MDs
- Currently receiving (or scheduled to receive) radiation treatment for a cancer listed in the inclusion criteria
- Age 18 years or older
- Fluent in English
- Radiation treatment for this cancer was completed (or will be completed) at MD Anderson Cancer Center (Post-RT study only)
Key exclusion criteria (8 listed)
- Overt cognitive difficulty demonstrated by not being clearly oriented to person or place or time
- Zubrod Performance Status >2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care
- History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)
- Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale
- Scheduled to receive or receiving unilateral radiation treatment for this cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life SurveyAlso: SurveyQuality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT. | Behavioural | CYCORE Group + Standard of Care, Standard of Care Group |
| Health Management SurveysAlso: QuestionnairesConfidence in health management survey; completed at baseline and 6 - 8 weeks after RT. | Behavioural | CYCORE Group + Standard of Care, Standard of Care Group |
| Monitoring DevicesHome use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer) | Other | CYCORE Group + Standard of Care |
| Symptoms SurveysBehavioral: Symptoms survey 1; completed at weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT. Behaviorial: Symptoms survey 2; completed at baseline, weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT. | Behavioural | CYCORE Group + Standard of Care, Standard of Care Group |
| Device Usability SurveyAlso: QuestionnaireDevice usability survey; completed at weeks 1, 3, 5, and 7 days after RT. | Behavioural | CYCORE Group + Standard of Care |
Primary outcome
Comparison Between the Two Groups of the Number of Hospitalizations and ER Visits Due to Dehydration
Time frame: 12 - 15 weeks
Primary outcome is proportion of patients who experience ER visits and/or hospitalizations related to dehydration (ERV) combined with ER visits resulting in hospitalization through the 6-7 weeks of RT. Primary analysis is comparison of proportion of patients in CYCORE group who have an ERV or ERHV and proportion of patients in the standard care group who have an ERV or ERHV. Analysis consists of a binomial test of two proportions using a continuity-corrected chi-square test. Analyses will follow the intention-to-treat principle, that is a patient in either arm who drops out is assumed to have an ERV and/or ERHV. For comparison purposes, data will be analyzed only using patients who have completed the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan K. Peterson, PHD, MPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Survey, Health Management Surveys and Monitoring Devices in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison Between the Two Groups of the Number of Hospitalizations and ER Visits Due to Dehydration (time frame: 12 - 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.