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

N/A

Waitlist Available

Led By Susan K. Peterson, PHD, MPH

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently receiving (or scheduled to receive) radiation treatment for a cancer listed in the inclusion criteria

Diagnosis of specified stage cancers in the head and neck region or other medically approved head and neck cancers

Must not have

Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale

Undergoing only palliative (not curative) radiation treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 - 15 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will help to see if home-use devices can help to lower hospitalizations and emergency room visits for patients with head and neck cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves monitoring devices rather than medications, side effects may include discomfort from wearing the devices or psychological impacts from constant health monitoring rather than physical drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

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My radiation treatment was or will be done at MD Anderson.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have swallowing difficulties not caused by my cancer.

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I have had radiation treatment for head and neck cancer.

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I am scheduled for or currently receiving radiation treatment on one side for my cancer.

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I have trouble recognizing people, places, or keeping track of time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 - 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 - 15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 - 15 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dehydration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care GroupExperimental Treatment3 Interventions

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

Group II: CYCORE Group + Standard of CareExperimental Treatment5 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.

0 / 11Eligibility criteria met