Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)
NCT01902966 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2021-10-12
Summary
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.
Conditions
Interventions
- DRUG
-
Propranolol
Starting dose: 20 mg is taken by mouth twice a day (40 mg/day).
- BEHAVIORAL
-
Diary
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.
- BEHAVIORAL
-
Questionnaires
Questionnaires completed at baseline, 2 months, and 4 months.
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Lois M. Ramondetta, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-11
- Primary Completion
- 2020-08-14
- Completion
- 2020-08-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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