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

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Breast Neoplasms

Hypertension

Essential Hypertension

Breast Diseases

Skin Diseases

Vascular Diseases

Channel Blockers

Bone Density Conservation Agents

Calcium

Diuretics

Calcium Channel Blockers

Calcium, Dietary

Hormones

Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers

Women with HTN exposed to calcium channel blockers but not exposed to other antihypertensive medicines

Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines.

Drugs with ATC code C08 will be categorised as calcium channel blockers.

Calcium channel blocker

Drugs with ATC code C07 will be categorised as beta-blockers.

Beta blocker

Drugs with ATC code C03 will be categorised as diuretics.

Diuretic

Drugs with ATC code C09 will be categorised as RAS (agents acting on the renin angiotensin system).

Drugs with ATC code C02 will be categorised as other antihypertensives.

Other AHT

None AHT

The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are:

* Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association.
* Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women.

The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.

Aims: To examine the association between long-term calcium channel blocker (CCB) use and the development of breast cancer.

Data sources: the Australian Longitudinal Study on Women's Health , 45 and Up Study, Rotterdam study and linked administrative data.

Study cohort: Women with self-reported hypertension (HTN) without prior breast cancer.

Harmonisation: Relevant variables will be checked for harmonisation in which variables available in all three cohort will be used in the harmonised analysis. The variables will be checked on the definition, measurement and harmonisation rules. Variables that cannot be harmonised across the cohorts will be used in the cohort specific analyses.

Exposure measurement: The primary exposure is the use of CCB, which will be identified by the anatomical therapeutic chemical code (C08) in the medicine data. Exposure to CCB as well as other antihypertensive (AHT) medicines will be captured separately as the cumulative dose-duration of exposure during follow up. Participants will be stratified in four groups: women with HTN with no AHT use, women with HTN exposed to CCB only, women with HTN exposed to non-CCB and women with HTN exposed to both CCB and non-CCB.

Outcome measurement: Data on a diagnosis of invasive breast cancer will be obtained from cancer registries and hospital admission data using ICD-10 code of C50.x.

Potential confounders: age, education, marital status, socioeconomic status, body mass index, diabetes, heart disease, stroke, age when had first child, parity, history of hysterectomy or oophorectomy, use of hormonal contraception, use of hormonal replacement therapy.

Statistical analysis: The association between CCB use and breast cancer risk will be estimated by the Fine and Gray competing risk regression model in which a first diagnosis of invasive breast cancer will be treated as the principle event and death and bilateral mastectomy (without a diagnosis of breast cancer) will be competing risks. The nonlinear threshold models will be used to capture any differential effect of the cumulative dose-duration of CCB while simultaneously accounting for the cumulative dose-duration of other AHT exposure on breast cancer risk. Other confounders will be accounted for in the models using propensity scores.

Implications: Results from this study will contribute to addressing the concerns about using CCB for hypertension treatment in women, particularly in those who have high risk of breast cancer.

Long-term Use of CCB and Breast Cancer Risk

Association of Long-term Use of Calcium Channel Blockers (CCB) and Risk of Breast Cancer: A Retrospective Longitudinal Observational Study

The outcome will be defined based on the ICD-10 code of C50.x (malignant neoplasm of breast).

Curtin University

Professor

Diseases and Abnormalities at or Before Birth

Ulcer

Congenital Abnormalities

Vascular Malformations

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Skin Abnormalities

Pharmaceutical Solutions

Anti-Infective Agents

Timolol

Mupirocin

Anti-Bacterial Agents

Enzyme Inhibitors

Half of enrolled subjects will receive topical Timolol

Half of enrolled subjects will receive Mupirocin

Dose-based escalation schedule for topical application:

4-8 kg: Day 0-7: 1 drop every other day; Day 7-14: 1 drop daily; Day 14 - Day 60: 1 drop twice per day

8-12 kg: Day 07: 1 drop daily; Day 7-14: 1 drop twice per day; Day 14 - Day 60: 2 drops twice per day

Timolol 0.5% Gel Forming Solution (GFS)

Topical application twice per day for 60 days

Mupirocin 2% Ointment

Albert C. Yan, MD

Vikash S. Oza, MD

Patrick McMahon, MD

The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.

Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities.

In the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize.

The use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics.

In this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.

Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)

The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas

A scoring system developed to measure clinical improvement of ulcerated hemangioma.

Glucose monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.

Glucose values \< 60 mg/dL will be considered significant.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Blood pressure monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.

Blood pressure values \< 3rd percentile (systolic or diastolic) will be considered significant for hypotension.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Pain will be assessed using the Wong-Baker faces scale.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of drainage or exudate, and/or culture positivity.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of active bleeding.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Glucose and vital sign monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.

Heart rate values \< 3rd percentile will be considered significant and indicative of bradycardia.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

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
Long-term Use of CCB and Breast Cancer Risk	NCT05972785	Hypertension,Es... Breast Cancer	Calcium channel... Beta blocker Diuretic RAS Other AHT None AHT	45 Years -	Curtin University
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)	NCT01408056	Infantile Heman...	Timolol 0.5% Ge... Mupirocin 2% Oi...	1 Month - 8 Months	Children's Hospital of Philadelphia

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