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

Nervous System Diseases

Cancer Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

Fentanyl

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

All patients 18 years of age and older with breakthrough cancer pain (BTcP) who are registered in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program and receiving Abstral® under the direction of a TIRF REMS Access program-registered physician are eligible for the study.

Patients or their proxy with a witness must be able to sign written informed consent to participate in the study; and the patient may also use a proxy caregiver to assist in the completion of the study questionnaires.

This Observational Registry study is designed to collect self-reported Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of treatment with Abstral® through the use of Quality of Life and pain measurement tools administered via questionnaire.

This is a post-marketing, single arm, open label multicenter trial to assess Abstral (fentanyl) Sublingual Tablets for breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients.

* Prior to study enrollment, patient enrollment in the TIRF REMS Access program must be confirmed.
* Eligible patients will sign written informed consent. Patients or their proxy with a witness must be able to sign written informed consent to participate in the study; and the patient may use a proxy caregiver to assist in the completion of the study questionnaires.
* Day 0, study site must enroll patient by completing a patient demographic profile (de-identified).
* Day 0, patient will be instructed how to use the questionnaires.
* Day 0, patient will complete the baseline questionnaire before leaving the physician office.
* On study Days 14, 21, and 28 (±3 days) patient questionnaire will be completed by patient (or caregiver proxy) via secure online data entry portal.
* For patients completing paper questionnaires, within 1 month of day 28, patient will return completed questionnaires via mail, fax or hand carried to the study site coordinator for processing.
* Patient will be considered to have completed the study successfully once all completed questionnaires have been received by the CRO within appropriate time limits.

Observational Registry Study of Quality of Life When Treating BTcP With Abstral

Rapid Evaluation of Lifestyle, Independence, and Elimination of Breakthrough Cancer Pain With Freedom From Oral Discomfort Through the Use of Abstral® (Fentanyl) Sublingual Tablets

Primary:

To compare self reported TIRF REMS Access-enrolled patient experience with BTcP at baseline (before using Abstral) to their experience after reaching a maintenance dose of Abstral

* Characterize the effectiveness of treatment with Abstral in select pain and quality-of-life (QoL) domains
* Abstral impact on pain interference with daily activities, somnolence, and oral health

Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described.

Galena Biopharma, Inc.

Infections

Carcinoma

Urinary Bladder Neoplasms

Communicable Diseases

Urinary Tract Infections

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Urologic Diseases

Male Urogenital Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Anti-Infective Agents

Antineoplastic Agents

Anti-Dyskinesia Agents

Micronutrients

Hematinics

Vitamins

Anti-Bacterial Agents

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Levofloxacin

Ofloxacin

Antibiotics, Antitubercular

Nitrofurantoin

Trimethoprim, Sulfamethoxazole Drug Combination

Trimethoprim

Sulfamethoxazole

Ertapenem

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

Trimethoprim-Sulfamethoxazole

Khurshid A. Guru

Khurshid A Guru

This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

PRIMARY OBJECTIVE:

I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.

SECONDARY OBJECTIVE:

I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ANTIBIOTIC): Patients receive ertapenem orally (PO), levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

GROUP II (CONTROL): Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

After surgery, patients are followed up to 120 days.

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.

stratified logistic regression models (stratified by antibiotic use)

Will be evaluated in patients who received prophylactic antibiotics.

To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.

Roswell Park Cancer Institute

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
Observational Registry Study of Quality of Life When Treating BTcP With Abstral	NCT01936636	Quality of Life Breakthrough Ca...	Fentanyl	18 Years -	Galena Biopharma, Inc.
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute
Observational Registry Study of Quality of Life When Treating BTcP With Abstral	NCT01936636	Quality of Life Breakthrough Ca...	Fentanyl	18 Years -	Galena Biopharma, Inc.

Spots Global Cancer Trial Database for diary

Every month we try and update this database with for diary 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 diary

Every month we try and update this database with for diary 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 diary 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.