Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Anxiety Disorders

Recurrence

Depression

Depressive Disorder

Uterine Cervical Neoplasms

Pain

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it. Questionnaires completed at baseline, 2 months, and 4 months.

Starting dose: 20 mg is taken by mouth twice a day (40 mg/day).

Patients record study medication taken each day in a pill diary. Relaxation diary completed after listening to audio sessions twice a week.

Diary

Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes.

Relaxation Audio Recording

Questionnaires completed at baseline, 2 months, and 4 months.

Questionnaires

Lois M. Ramondetta, MD

The goal of this clinical research study is to learn how many patients with advanced, recurrent, incurable cervical cancer will complete questionnaires about symptoms, any anxiety, depression, and/or pain, and the quality of their lives. Researchers also want to learn how many of these patients will complete a study treatment of propranolol hydrochloride and relaxation and guided imagery sessions.

Researchers also want to learn if and how propranolol hydrochloride and relaxation and guided imagery may affect cancer symptoms and any anxiety, depression, and/or pain, and quality of life.

Propranolol hydrochloride is designed to block certain chemicals that affect the heart.

Relaxation and guided imagery sessions are a form of relaxing meditation that involves tensing and relaxing various parts of your body from your feet to your head. In the guided imagery portion, you listen to recordings that are designed to help with calmness, control, and decreasing stress.

Study Therapy Administration:

If you are found to be eligible to take part in this study, you will take propranolol by mouth 2 times a day.

While taking the drug, you should continue to check your blood pressure daily with your own personal blood pressure machine, at your local pharmacy, or in the clinic. If you are personally monitoring your blood pressure, you should contact the research nurse if the systolic blood pressure (SBP - the higher number) is less than 110, or if the diastolic (DBP - the lower number) is less than 50 (or your heart rate is 50-60 and you show symptoms at 2 different timepoints 24 hours apart). The study doctor may decide to lower or raise your dose of study drug during the study based on your heart rate and/or blood pressure measurements.

You will fill out a pill diary to write down the doses of propranolol that you take each day.

For the relaxation and guided imagery sessions, you will be given an MP3 player with an audio recording that you should listen to 2 times a week for up to 4 months (or longer if you choose). The study staff will talk to you about how to complete the sessions. You will fill out a relaxation diary to write down whether you were able to complete the sessions and whether you had any difficulties with it, such as distractions.

You should bring both diaries to the clinic at each visit.

Study Visits:

At Month 1:

* Your vital signs will be measured.
* You will be asked about any side effects you may have had.

At Months 2 and 4:

* Your vital signs will be measured.
* You will be asked about any side effects you may have had. Blood (about 5-6 teaspoons) will be drawn for routine tests and for testing on cytokines, RNA, and tumor markers.
* You will complete the same questionnaires as at screening.
* If the doctor thinks it is needed, you will have an EKG to check your heart function.
* If you are an MD Anderson participant, the test to find out how many calories you need to have on a daily basis will be repeated.
* At Month 2 only, if the doctor thinks it is needed, you will have a CT scan of the chest, abdomen, and pelvis to check the status of the disease.
* At Month 4 only, any updates to your medical history will be recorded. You will have a physical exam.

Length of Treatment:

You may continue the study therapy for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your active participation on the study will be over after the last visit. The study staff will continue checking your medical record from then on to see how you are doing.

This is an investigational study. Propranolol is FDA approved and commercially available to treat certain heart and blood pressure problems, anxiety, migraines, and tremors. Its use in this study is investigational.

Up to 20 participants will be enrolled in this multicenter study. Up to 5 will be enrolled at the Harris Health System. Up to 10 will be enrolled at MD Anderson.

Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)

Effect of a Beta Adrenergic Blockade Combined With Relaxation/Guided Imagery Audio Intervention on Symptom Distress in Women With Advanced, Recurrent Incurable Cervical Cancer - Feasibility Study

To determine the proportion of patients completing symptom inventory, anxiety and depression survey, pain inventory, and quality of life surveys (MDASI, HADS\< BPI, FACT-Cx).

M.D. Anderson Cancer Center

A starting dose of propranolol 20 mg is taken by mouth twice a day (40 mg/day). If patient tolerates the initial dose (no hypotension or bradycardia), dose increased to 40 mg by mouth twice a day at start of second month of therapy. Patients record study medication taken each day in a pill diary. Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes. Relaxation diary completed stating whether patient was able to complete the sessions and whether they had any difficulties with it.

Propranolol + Relaxation/Guided Imagery

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Due to early termination, low accrual and lack of funding unable to determine the primary outcome.

Lois M. Ramondetta, MD, Professor, Gynecologic Oncology & Reproductive Medicine

data were not collected due to protocol terminated early.

Proportion of Patients Completing Symptom Inventories

Overall Study

Nutritional and Metabolic Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Emergencies

Dehydration

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Water-Electrolyte Imbalance

Metabolic Diseases

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
Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)	NCT01902966	Cervical Cancer	Propranolol Diary Relaxation Audi... Questionnaires	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
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
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 quality of life survey