Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Dehydration

Death

Water-Electrolyte Imbalance

Metabolic Diseases

Survey of Palliative care physicians from Latin America and Spain

10-15 minute online survey to assess palliative care physicians' attitudes, beliefs and practice patterns related to parenteral hydration at the end of life in Latin America and Spain.

Survey

Isabel Torres, MPH, DRPH

The purpose of this study is to assess palliative care physicians' attitudes, beliefs and practice patterns related to parenteral hydration at the end of life in Latin America and Spain.

Objectives:

1. To assess palliative care physicians' attitudes, beliefs and practice patterns related to parenteral hydration at the end of life in Latin America and Spain.
2. To assess cross-national differences in practice patterns related to parenteral hydration at the end of life. (Latin America vs. Spain).
3. To determine the percentage of physicians who practice parenteral hydration at the end-of-life in the hospital setting and the home setting.
4. To examine the association between providers' parenteral hydration practice patterns and:

   * 1. provider demographic characteristics;
   * 2. specific characteristics of their practice settings; and
   * 3. training and experience in end of life care;
5. To determine which factors most predict the practice of parenteral hydration at the end of life among palliative care physicians.

This study is a collaboration between MD Anderson's Departments of Palliative care and Rehabilitation Medicine, Health Disparities Research, the Latin American Association for Palliative Care (ALCP) and the Spanish Society for Palliative Care (SECPAL). The proposed study involves a 10-15 minute online survey of palliative care physicians from Latin America and Spain to assess their attitudes, beliefs and practice patterns related to parenteral hydration at the end of life.

Physician Perceptions About Parenteral Hydration in Latin America and Spain

Physician Perceptions About Parenteral Hydration in Latin America and Spain: A Survey of Physicians Affiliated With the Latin American Association for Palliative Care (ALCP) and the Spanish Society for Palliative Care (SECPAL)

M.D. Anderson Cancer Center

Neoplasms

Digestive System Diseases

Rare Diseases

Emergencies

Esophageal Neoplasms

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Acute Graft Versus Host Disease

All Drugs and Chemicals

Immunomodulating Agents

Standard of care nutritional support with the addition of daily Gatorade G2

Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)

Gatorade G2

Standard of care nutritional support

Elisha Fredman, MD

The purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head \& neck (H\&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy.

Among patients with cancer of the H\&N or esophagus, complications related to dehydration are fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even inpatient admission. By instructing participants to drink a reasonable amount of a common electrolyte-rich energy drink from the initiation of treatment through its completion, the hypothesis will be tested that this inexpensive and easily administered preventative strategy can significantly decrease the rate of ACC and ED visits.

The objectives of this study are to decrease the frequency of ACC visits during the course of radiation therapy and decrease the frequency of ED visits during the course of radiation therapy. The study team also seeks to decrease the incidence of orthostatic vital signs during the course of radiation therapy and decrease the number of days of missed treatments due to radiation toxicity during the course of radiation therapy.

In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course of radiation, along with standard of care nutritional support from dietitians. The randomized Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional support. Group 2 will receive standard of care nutritional support plus the study agent, Gatorade G2.

DRIHNC - Dehydration Reduction in Head & Neck Cancer

DRIHNC - Dehydration Reduction in Head & Neck Cancer: Daily Oral Fluid and Electrolyte Maintenance to Prevent Acute Care Clinic and Emergency Department Visits for Patients Receiving Radiation With or Without Chemotherapy/Immunotherapy for Head & Neck and Esophageal Cancer.

ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.

Number of missed days of radiation treatment among H\&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.

Case Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Mouth and Tooth Diseases

Lung Neoplasms

Mucositis

Stomatitis

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

The Symptom Management Education and Nurse Coaching (SMENC) intervention is a one hour in-person face-to-face education session followed by twice weekly telephone calls conducted all throughout the patient's chemoradiation treatment regimen.

During the telephone call, the patient will report the use of the Drinks Diary.

The registered nurse (RN) will teach good mouth care and management of sore mouth or throat (mucositis) symptoms to the patient for self-management at home. The RN will then call the patient twice every week to continue educating and coaching the patient about the mucositis self-management. The patient will receive the Symptom Management (SxM) Toolkit which is a written educational guide known as the "Cancer Treatment Symptom Management Education Toolkit" geared to help the patient manage their symptoms of sore mouth and throat at home in order to prevent dehydration.

Symptom Management Education and Nurse Coaching

The patient will complete the Drinks Diary daily by recording the all oral fluid ingested and also record the number of times the bathroom is used.

Drinks Diary

Raphael Yechieli, MD

This is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.

Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration

Feasibility Study of a Nurse-Delivered Telephone Intervention To Impact Mucositis Symptom Severity and Prevent Dehydration in Lung and Head/Neck Cancer Patients Undergoing Chemoradiation: A Pilot Study

Defined as the number of participants that completed 80% of the total 12 calls.

Amount of time of the patient daily phone call (in minutes).

Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).

Attrition rate will be comprised of those study participants who drop out of the study and be computed as a percent.

Length of time spent in the study will be expressed as a percent and it is expected that the participants will complete 75% of their planned chemoradiation treatments.

Qualitative analysis of a customized Semi-Structured Interview

Mucositis severity will be measured daily by the Oral Mucositis Daily Questionnaire (OMDQ).

A score of 0 equals no mucositis severity and high mucositis severity equals a score of 4 on question 2.

The M.D. Anderson Symptom Inventory - Lung Cancer / Head \& Neck Cancer(MDASI-LC; MDASI-HN) will be used to measure overall severity.

The total MDASI-LC; HN score will be used in the analysis of overall symptom severity. Friedman's test is the test statistic that will be used to measure the effect of the intervention on overall symptom severity per cycle of chemoradiation treatment.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy - Lung and Head \& Neck versions (FACT-L; FACT-H\&N respectively ). The FACT-L \& FACT H\&N are both a five domain, 36 item self-report instrument scored on a 5 point Likert scale (zero to 4) with a score range of 0-144; the higher the score = higher HRQoL.

Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration.

The adapted Chronic Disease Self-Efficacy Scale (CDSES) was developed by combining the subscales of Manage Disease in General Scale and the Symptoms Scale for a combined 10 item scale to measure the concept of perceived self-efficacy. Each item is scored 0 to 8; with the higher combined sum score equating to a higher perceived self-efficacy in the participant.

The Partners in Health Scale (PIHS) was designed to measure adherence to treatment, knowledge of disease, management of side effects and management of signs and symptoms over time. The 12 item questionnaire scores each question among the domain categories on a 9 point scale from 0-8 and the higher sum score reflects a higher self-management in the participant.

University of Miami

Associate Professor of Clinical Medicine

Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily

Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Saline

100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Eduardo Bruera, MD

The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration.

Objectives:

1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care.

1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care.

1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.

For Caregivers:

Symptoms of dehydration may include fatigue, muscle contractions, the need for sedation (calming medication), and hallucinations (where something is sensed that is not actually there). Hydration allows the body to get rid of the waste products from medications and other chemicals. When the fluid levels in the body are increased, the brain function may directly improve.

If the patient under your care is found to be eligible to take part in this study, he or she will be randomly assigned (as in the toss of the coin) to one of 2 groups. Participants in Group 1 will receive normal saline (salt water) once a day. Participants in Group 2 will receive a lower amount of normal saline once a day. This lower amount is small enough to be considered a placebo. Doctors call something a placebo if it looks like the substance being tested but has no active ingredients (or in this case, few active ingredients).

Both you and the patient will be asked to complete a number of questionnaires at the beginning of the study, on Days 1-7, and then every 3-5 days after that. Your questionnaires will ask about the feelings you may have about hydration and the care that you are providing to the patient. Each day's questionnaires will take about 30 minutes.

Both you and the patient will also be interviewed by researchers at the beginning of the study and on Day 4 (+/- 2 days). The interviews will include questions about what it has been like for the patient to get fluids, whether the fluid was more like food or medicine, whether the patient has ever gotten dehydrated, and how you manage the patient's care. The interviews should each take about 30 minutes. The interviews in this study will be audio taped so the information can be studied by researchers. Only the research staff will listen to the audio tape of the interviews.

If the patient goes off study, your participation in the study will be over.

This is an investigational study. Up to 150 patients and 150 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

For Patients:

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will be asked to complete a questionnaire. It will ask questions about your cancer diagnoses, the medications you are taking, and the symptoms you are having. The questionnaire also asks about your memory of being dehydrated, what it was like for you to get fluids, how you manage your care, and whether the fluid was more like food or medicine. It should take about 30 minutes to complete.

Both you and your caregiver will also be interviewed by researchers. There will be questions about what it has been like for you to get fluids, whether the fluid was more like food or medicine, and whether you have ever gotten dehydrated. Each interview should take about 30 minutes. The interviews in this study will be audio taped so the information can be studied by researchers.

The study staff will also check you for symptoms of muscle contraction, one of the signs of dehydration. The study staff will videotape your face, arms, hands, legs and toes for a total 3-5 minutes on Days 1, 4, and 7, and then every 3-5 days after that.

As part of the screening tests, you will also have blood drawn (about 2 teaspoons) for routine tests. You will be asked questions about your ability to perform daily activities (performance status evaluation). You will be asked about any side effects you may have, including muscle contractions. You will also be asked to list any pain medications or other medications that you take.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of the coin) to one of two groups. Participants in Group 1 will receive normal saline (salt water) once a day. Participants in Group 2 will receive a lower amount of normal saline once a day. This lower amount is small enough to be considered a placebo. Doctors call something a placebo if it looks like the substance being tested but has no active ingredients (or in this case, few active ingredients). You will have an equal chance of being placed in either group. Neither you nor any of the medical staff or researchers on this study will know which dose you are receiving.

The research nurse will ask you to complete several questionnaires that ask questions about dehydration and the symptoms you may have experienced, including fatigue. The questionnaires will be completed on Days 1-7, and then every 3-5 days after that. In total, each day's questionnaires should take about 30 minutes. Your caregiver will also be asked about his or her memory of your dehydration. On Day 7, you will have blood drawn (about 2 teaspoons) for routine tests.

Both you and your caregiver will also be interviewed by researchers on Day 4 (+/- 2 days), and then every 3-5 days after that. The interviews will be like the ones at screening.

Starting on Day 1 of the study, you will receive saline through a catheter in a vein (over 4 hours) every day. If you already have a central venous catheter, you will receive the saline through that catheter. If you do not have a central venous catheter, the saline will be infused under the skin. Either way, the infusion will last about 4 hours.

During each infusion, an infusion research nurse will check to make sure that the saline is given properly. This nurse will know which treatment group you have been assigned to.

Every day, the research nurse will ask you about the dehydration and any side effects you may have. Every day, the research nurse will also check the place where the infusion is given to make sure there is no infection.

On Days 1-7 and then every 3-5 days, the research nurse will also check for any dehydration symptoms including the need for sedation, any restless feelings or actions, and/or muscle contractions. You will have a performance status evaluation daily. On Days 1-7, the research nurse will ask about any pain medications or other medications that you have taken.

Every day, 2 hours \[+/- 3 hours\] after the infusion ends, you will also be checked by an assessment research nurse who will not know which treatment group you are in. The assessment research nurse will ask about any symptoms you may have. The study staff will also check you for symptoms of muscle contraction, one of the signs of dehydration. The study staff will videotape your face, arms, hands, legs and toes for a total 3-5 minutes on Days 1, 4, and 7, and then every 3-5 days after that.

You may remain on study to receive the daily infusions for as long as you are benefitting up to Day 14 \[+/- 3 days\]. On Day 14 \[+/- 3 days\] you will be taken off study, and you will have off study assessments, which include questions about your symptoms including fatigue, performance status, medications you are taking, and dehydration symptoms. If intolerable side effects occur, you will be taken off study and given appropriate medical care. If you wish to continue receiving hydration fluids after you are taken off study \[Day 14 +/- 3 days\], you may discuss this option with your attending hospice physician. You may receive a liter of normal saline each day under the skin. Treatment will be given by hospice nurse. Fluid will be provided to you free of charge.

This is an investigational study. Up to 150 patients and 150 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Parenteral Hydration in Advanced Cancer Patients

Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial

Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.

Participants rated delirium, quality of life, and overall survival using Richmond agitation sedition scale (RASS) where +4 is "Combative" to -5 is "Unarousable"; Memorial delirium assessment scale (MDAS), a ten-item, clinician-rated scale from 0 (none) to 3 (severe) for severity of delirium, for a total range of 0-30; and Unified Myoclonus Rating Scale (UMRS) 5-functional scores rated 0 to 4, for a total range of 0-20 where higher scores indicate more severe involuntary movements. Higher scores indicate worse outcomes for each scale, i.e. RASS more agitation, MDAS more delirium and UMRS more severe involuntary movements. The mean represents change in combined participant daily scores for each scale between Baseline and Day 4 assessments then separately Day 7 assessments. Reported value is mean of average change in patients' scores per group. Reported values reflect changes from baseline, either median decreases (less than 0), no change (0) or increases (greater than 0).

Change between Day 7 to Baseline in FACIT-F (Functional Assessment of Chronic illness Therapy-Fatigue) \& FACT-G (Functional Assessment of Cancer Therapy-General) scores. Participants rate quality of life using FACT-G consisting of 33 questions with 5 domains assessing physical and social, emotional \& functional well being \& relationship with physician, remaining 5 assess extent to which each domain affects overall quality of life on 5-point scale from 0 (not at all) to 4 (very much); total score obtained by summing individual subscale scores (0-132). FACIT-F consists of 13 items where participants rate intensity of fatigue \& its related symptoms on a scale of 0-4 from 0 "not at all" to 4 "very much." The responses to FACIT fatigue questionnaire are each measured on 4-point Likert scale with total score ranges from 0 to 52. High scores represent less fatigue. Reported is the mean change of the summed value of all reported scores for the FACT-G or the FACIT-F from baseline to Day 7.

Secondary outcomes included delirium, quality of life, and overall survival. The Nursing delirium screening scale (NuDESC) was used to assess delirium. NuDESC is a validated observational instrument conducted by research staff based on input from family caregivers. Five symptoms (disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation) are each given a score from 0 to 2, for a possible total score of 10. A higher NuDESC score indicates increased symptoms of delirium. It was observed a trend for lesser decline (delirium) in the hydration group, and significant worsening of night-time NuDESC scores in the placebo group.

Dehydration was assessed by using the Dehydration Assessment Scale on the basis of three physical findings, moisture on the mucous membranes of the mouth (0=moist, 1=somewhat dry, 2=dry), axillary moisture (0=moist, 1=dry) and sunkenness of the eyes (0=normal, 1=slight sunken, 2=sunken). These signs are selected due to their significant correlations with biological dehydration, as previously confirmed by elderly patients. The dehydration score (range 0-7) is calculated as the total of these 3 scores, a higher score indicates a higher level of dehydration. The reported value was the mean of average change in patients' scores per group.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Hydration

Placebo

Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Hydration: Normal Saline (Salt Water)

Placebo: Lower Saline

Total

Age, Continuous

<=18 years

Between 18 and 65 years

>=65 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Study had a planned sample size of 150 participants but due to funding issues recruitment was halted after 129 patients; additionally, participants with delirium or severe dehydration were excluded for logistic purposes.

Dr. Eduardo Bruera, MD / Professor

Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Participant Reduced Symptom Burden

RASS

MDAS

UMRS

Hydration (Baseline and Day 4)

Placebo (Baseline and Day 4)

Hydration (Baseline and Day 7)

Placebo (Baseline and Day 7)

Reduced Symptom Burden as Measured by RASS, MDAS and UMRS

FACT-G

FACIT-F

Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7

NuDESC Day

NuDESC Evening

NuDESC Night

Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)

Change in Dehydration as Measured by Dehydration Assessment Scale

Overall Study

Behaviors and Mental Disorders

Neoplasm Metastasis

Syndrome

Quality of Life

Culturally Tailored Nurse Symptom Management group (CTNSM) - participants in the CTNSM group will receive one in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message during the first 12 weeks of standard of care chemotherapy. In addition, participants can receive standard of care chemotherapy education.

Participants in the control group will only be receiving the standard of care chemotherapy education.

The Culturally Tailored Nurse-delivered telephone/text message symptom-management intervention (CTNSM) intervention is an in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message conducted for the first 12 weeks of standard of care chemotherapy .

CTNSM

Standard of Care chemotherapy education is a one-time patient education session about general treatment-related side effects patients can experience from chemotherapy and the interventions to mitigate the symptoms.

Standard of Care Chemotherapy Education

Natasha Solle, PhD

The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.

Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer

MD Anderson Symptom Inventory (MDASI) is a 19 item scale with a score range from 0-10 per symptom question that measures symptom severity plus symptom interference combined to measure total symptom burden. The higher score indicates worsening of symptoms.

Incidents of unscheduled medical visits for IV hydration

The CDSES is a 10 item scale with a score range from 0-10 per symptom question that measures perceived self-efficacy. The higher score indicates better perceived self-efficacy.

The PIHS is a 12 item scale with a score range from 0-8 per question that measures symptoms self-management. The higher score indicates better symptom self-management.

Feasibility will be reported as a percentage of completed calls or text messages.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Breast (FACT-B). FACT-B has a total scoring of 0-148 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Prostate (FACT-P). FACT-P has a total scoring of 0-156 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Colon (FACT-C). FACT-C has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Lung Cancer (FACT-LC). FACT-LC has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Oncology Nursing Society

assistant research professor

Ear, Nose, and Throat Diseases

Nasopharyngeal Carcinoma

Mouth Neoplasms

Oral Cancer

Hypopharyngeal Cancer

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

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.

Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT.

Quality of Life Survey

Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.

Health Management Surveys

Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer)

Monitoring Devices

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.

Symptoms Surveys

Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.

Device Usability Survey

Susan K. Peterson, PHD, MPH

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.

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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Physician Perceptions About Parenteral Hydration in Latin America and Spain	NCT01011140	Dehydration Advanced Cancer...	Survey	18 Years -	M.D. Anderson Cancer Center
DRIHNC - Dehydration Reduction in Head & Neck Cancer	NCT03799380	Dehydration Head & Neck Can... Esophageal Canc...	Gatorade G2 Standard of car...	18 Years -	Case Comprehensive Cancer Center
Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration	NCT03416582	Lung Cancer Mucositis Oral Dehydration Head and Neck C...	Symptom Managem... Drinks Diary	18 Years -	University of Miami
Parenteral Hydration in Advanced Cancer Patients	NCT00423722	Advanced Cancer Dehydration	Saline Saline	18 Years -	M.D. Anderson Cancer Center
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management	NCT04874584	Dehydration Symptom Cluster Quality of Life Self Efficacy Chemotherapy Ef...	CTNSM Standard of Car...	18 Years -	University of Miami
Parenteral Hydration in Advanced Cancer Patients	NCT00423722	Advanced Cancer Dehydration	Saline Saline	18 Years -	M.D. Anderson Cancer Center
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients	NCT02253238	Head and Neck C...	Quality of Life... Health Manageme... Monitoring Devi... Symptoms Survey... Device Usabilit...	18 Years -	M.D. Anderson Cancer Center
Physician Perceptions About Parenteral Hydration in Latin America and Spain	NCT01011140	Dehydration Advanced Cancer...	Survey	18 Years -	M.D. Anderson Cancer Center
Parenteral Hydration in Advanced Cancer Patients	NCT00423722	Advanced Cancer Dehydration	Saline Saline	18 Years -	M.D. Anderson Cancer Center
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients	NCT02253238	Head and Neck C...	Quality of Life... Health Manageme... Monitoring Devi... Symptoms Survey... Device Usabilit...	18 Years -	M.D. Anderson Cancer Center
Physician Perceptions About Parenteral Hydration in Latin America and Spain	NCT01011140	Dehydration Advanced Cancer...	Survey	18 Years -	M.D. Anderson Cancer Center
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients	NCT02253238	Head and Neck C...	Quality of Life... Health Manageme... Monitoring Devi... Symptoms Survey... Device Usabilit...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for dehydration

Every month we try and update this database with for dehydration cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dehydration

Every month we try and update this database with for dehydration cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dehydration cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.