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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 : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Propranolol Behavioral: Diary Behavioral: Relaxation Audio Recording Behavioral: Questionnaires Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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.
Drug: Propranolol
Starting dose: 20 mg is taken by mouth twice a day (40 mg/day).
Other Names:
  • Betachron
  • Inderal

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.
Other Name: Surveys




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Proven recurrent cervical cancer of any histology not eligible for curative radiotherapy or surgery.
  2. Failed chemotherapy for first recurrence (excluding chemotherapy with concurrent irradiation) or refractory to first line systemic therapy.
  3. Measurable or non-measurable disease
  4. Unlimited prior therapies

Exclusion Criteria:

  1. Patients whose disease may be cured by surgery or radiotherapy.
  2. Contraindication to use of a beta-blocker.(uncontrolled DM, COPD-unstable, Bradycardia <50 BPM)
  3. Already receiving a beta-blocker.
  4. Performance status >3. Must have had treatment for first line recurrence
  5. 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.
  6. 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.
  7. Use of systemic glucocorticoids such as Prednisone or Decadron in the last month for greater than one week
  8. Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish.
  9. Cirrhosis of the liver
  10. Patients under the age of 18
  11. History of comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis.
  12. Hypersensitivity to propranolol, or beta-blockers
  13. Uncompensated congestive heart failure
  14. Cardiogenic shock
  15. Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome (if no artificial pacemaker present)
  16. Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)
  17. Any patients on Avastin or any other anti-angiogenic drugs.
  18. 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."
  19. Patients participating in or who plan to participate in other treatment trials during the course of this study.
  20. Patients actively using cocaine
  21. Cannot be receiving any other active neoplastic treatment during 4 months of study.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01902966     History of Changes
Other Study ID Numbers: 2013-0113
NCI-2013-02078 ( Registry Identifier: NCI CTRP )
G-12-300 ( Other Identifier: Foundation Grant )
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Propranolol
Adrenergic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents