Cervical CancerNCT01902966
Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)
A study testing Propranolol, Diary and Relaxation Audio Recording in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Propranolol, Diary and Relaxation Audio Recording
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2013to 14 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven recurrent cervical cancer of any histology not eligible for curative radiotherapy or surgery.
- Failed chemotherapy for first recurrence (excluding chemotherapy with concurrent irradiation) or refractory to first line systemic therapy.
- Measurable or non-measurable disease
- Unlimited prior therapies
Who cannot join
- Patients whose disease may be cured by surgery or radiotherapy.
- Contraindication to use of a beta-blocker.(uncontrolled DM, COPD-unstable, Bradycardia <50 BPM)
- Already receiving a beta-blocker.
- Performance status >3. Must have had treatment for first line recurrence
- Prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease.
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
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- Use of systemic glucocorticoids such as Prednisone or Decadron in the last month for greater than one week
- Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish.
- Cirrhosis of the liver
- Patients under the age of 18
- History of comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis.
- Hypersensitivity to propranolol, or beta-blockers
- Uncompensated congestive heart failure
- Cardiogenic shock
- Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome (if no artificial pacemaker present)
- Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)
- Any patients on Avastin or any other anti-angiogenic drugs.
- Patients with brittle diabetes mellitus (DM). Brittle diabetes mellitus is a type of diabetes when a person's blood glucose (sugar) level often swings quickly from high to low and from low to high. Also called "unstable diabetes" or "labile diabetes."
- Patients participating in or who plan to participate in other treatment trials during the course of this study.
- Patients actively using cocaine
- Cannot be receiving any other active neoplastic treatment during 4 months of study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital (LBJ)
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cervical Cancer
- Being tested
- Propranolol, Diary, Relaxation Audio Recording, Questionnaires
- Keywords
- Cervical Cancer, Propranolol, Betachron, Inderal, Beta blocker, Questionnaires, Surveys, Symptom inventory, Anxiety and depression survey, Pain inventory, Quality of life survey, Relaxation audio recording, MP3 player, Diary
- Medical subject headings
- Uterine Cervical Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Betachron, Inderal
Starting dose: 20 mg is taken by mouth twice a day (40 mg/day).
DiaryBehavioural
Patients record study medication taken each day in a pill diary. Relaxation diary completed after listening to audio sessions twice a week.
Relaxation Audio RecordingBehavioural
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.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline, 2 months, and 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol + Relaxation/Guided Imagery | Experimental | 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. Receives: Drug: Propranolol; Behavioral: Diary; Behavioral: Relaxation Audio Recording; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study start11 Sep 2013
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Why it stopped: low accrual and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lois M. Ramondetta, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902966
- Sponsor's protocol ID
- 2013-0113
- Other IDs
- NCI-2013-02078, G-12-300
- Status last verified
- Sep 2021
- First submitted
- 12 Jul 2013
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01902966
- Acronym / sponsor ID
- 2013-0113
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Propranolol, Betachron, Inderal, Beta blocker, Questionnaires, Surveys, Symptom inventory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual and lack of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Sep 2013 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propranolol + Relaxation/Guided Imagery | Experimental | Drug: Propranolol, Behavioral: Diary, Behavioral: Relaxation Audio Recording, Behavioral: QuestionnairesA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Proven recurrent cervical cancer of any histology not eligible for curative radiotherapy or surgery.
- Failed chemotherapy for first recurrence (excluding chemotherapy with concurrent irradiation) or refractory to first line systemic therapy.
- Measurable or non-measurable disease
- Unlimited prior therapies
Key exclusion criteria (21 listed)
- Patients whose disease may be cured by surgery or radiotherapy.
- Contraindication to use of a beta-blocker.(uncontrolled DM, COPD-unstable, Bradycardia <50 BPM)
- Already receiving a beta-blocker.
- Performance status >3. Must have had treatment for first line recurrence
- Prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAlso: Betachron, InderalStarting dose: 20 mg is taken by mouth twice a day (40 mg/day). | Drug | Propranolol + Relaxation/Guided Imagery |
| DiaryPatients record study medication taken each day in a pill diary. Relaxation diary completed after listening to audio sessions twice a week. | Behavioural | Propranolol + Relaxation/Guided Imagery |
| Relaxation Audio RecordingPatient 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. | Behavioural | Propranolol + Relaxation/Guided Imagery |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline, 2 months, and 4 months. | Behavioural | Propranolol + Relaxation/Guided Imagery |
Primary outcome
Proportion of Patients Completing Symptom Inventories
Time frame: 2 months
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lois M. Ramondetta, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol, Diary and Relaxation Audio Recording in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Completing Symptom Inventories (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.