Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01902966|
Recruitment Status : Active, not recruiting
First Posted : July 18, 2013
Last Update Posted : January 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: Propranolol Behavioral: Diary Behavioral: Relaxation Audio Recording Behavioral: Questionnaires||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Actual Study Start Date :||September 11, 2013|
|Estimated Primary Completion Date :||September 28, 2020|
|Estimated Study Completion Date :||September 28, 2020|
Experimental: Propranolol + Relaxation/Guided Imagery
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.
Behavioral: Relaxation Audio Recording
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.
Questionnaires completed at baseline, 2 months, and 4 months.
Other Name: Surveys
- Proportion of Patients Completing Symptom Inventories [ Time Frame: 2 months ]Trial defined to be feasible if Functional Assessment of Chronic Illness Therapy-Cervix (FACT Cx), Brief Pain Inventory (BPI), Hospital Anxiety and Depression Scale (HADS), and MD Anderson Symptom Inventory (MDASI) scores can be calculated for 87% of subjects (13 out of 15) at Month 2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902966
|United States, Texas|
|Lyndon B. Johnson General Hospital (LBJ)|
|Houston, Texas, United States, 77030|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Lois M. Ramondetta, MD||M.D. Anderson Cancer Center|