An interventional study of Propranolol and Diary in Cervical Cancer, sponsored by M.D. Anderson Cancer Center. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care
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:
At Months 2 and 4:
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 6 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Propranolol · Behavioral: Diary · Behavioral: Relaxation Audio Recording · Behavioral: Questionnaires
Starting dose: 20 mg is taken by mouth twice a day (40 mg/day).
Also known as: Betachron, Inderal
Patients record study medication taken each day in a pill diary. Relaxation diary completed after listening to audio sessions twice a week.
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.
Also known as: Surveys
Proportion of Patients Completing Symptom Inventories
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).
Time frame: 2 months
Recruitment period: 09/2013 until 02/2015. All the recruitment was done in a medical clinic setting.
| Milestone | Propranolol + Relaxation/Guided Imagery |
|---|---|
| Started | 5 |
| Completed | 2 |
| Not completed | 3 |
| Withdrew: Death | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
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).
No measurements were reported for this outcome.
Collected over baseline, 2 months and 4 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propranolol + Relaxation/Guided Imagery | 1/5 (20%) | 1/5 (20%) | 2/5 (40%) |
| Event | Propranolol + Relaxation/Guided Imagery |
|---|---|
| Urine Output decreasedInvestigations | 1/5 |
| Event | Propranolol + Relaxation/Guided Imagery |
|---|---|
| HypotensionVascular disorders | 2/5 |
| PainGeneral disorders | 2/5 |
| Edema limbsGeneral disorders | 1/5 |
| FatigueGeneral disorders | 1/5 |
| DizzinessNervous system disorders | 1/5 |
| HeadacheNervous system disorders | 1/5 |
| NauseaGastrointestinal disorders | 1/5 |
| VomitingGastrointestinal disorders | 1/5 |
| ConstipationGastrointestinal disorders | 1/5 |
| HyperkalemiaMetabolism and nutrition disorders | 1/5 |
All registered participants.
| Age, Categorical(Participants) | Propranolol + Relaxation/Guided Imagery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 1 |
| Age, Continuous(years) | Propranolol + Relaxation/Guided Imagery |
|---|---|
| Median | 50 (31 to 74) |
| Sex: Female, Male(Participants) | Propranolol + Relaxation/Guided Imagery |
|---|---|
| Female | 6 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Propranolol + Relaxation/Guided Imagery |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Propranolol + Relaxation/Guided Imagery |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Propranolol + Relaxation/Guided Imagery |
|---|---|
| United States | 6 |
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M.D. Anderson Cancer Center