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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 - 15 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am currently undergoing or scheduled for radiation treatment for my cancer.
Select...
I have been diagnosed with a specific stage of cancer in the head or neck.
Select...
I am 18 years old or older.
Select...
My radiation treatment was or will be done at MD Anderson.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 - 15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 - 15 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dehydration
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.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,975 Previous Clinical Trials
1,789,092 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,675 Previous Clinical Trials
40,926,550 Total Patients Enrolled
Susan K. Peterson, PHD, MPHPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have a condition that makes it hard for me to stand on a scale.I am 18 years old or older.I am receiving radiation treatment for symptom relief, not to cure my disease.I am currently getting radiation treatment for cancer within the MDACC Cancer Network.I spend most of my day in bed or seated and need help with personal care.My radiation treatment was or will be done at MD Anderson.I have swallowing difficulties not caused by my cancer.I have had radiation treatment for head and neck cancer.I am scheduled for or currently receiving radiation treatment on one side for my cancer.I have trouble recognizing people, places, or keeping track of time.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Group
- Group 2: CYCORE Group + Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently seeking participants for this research?
"According to the latest information on clinicaltrials.gov, this study is not presently seeking patients. The study was initially posted on 1/1/2014 and was last edited on 6/29/2022. Although this clinical trial is not recruiting patients at this time, there are 516 other studies currently recruiting participants right now."
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Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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