Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)

NCT01902966 | Terminated Results FDA Drug

• 3 other identifiers: 2013-0113NCI-2013-02078G-12-300
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Cancer

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

Outcome Measures

Primary Outcomes (1)

• 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).

  2 months

Study Arms (1)

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.

Drug: Propranolol; Behavioral: Diary; Behavioral: Relaxation Audio Recording; Behavioral: Questionnaires

Interventions

Propranolol DRUG

Starting dose: 20 mg is taken by mouth twice a day (40 mg/day).

Also known as: Betachron, Inderal

Propranolol + Relaxation/Guided Imagery

Diary BEHAVIORAL

Patients record study medication taken each day in a pill diary. Relaxation diary completed after listening to audio sessions twice a week.

Propranolol + Relaxation/Guided Imagery

Relaxation Audio Recording BEHAVIORAL

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.

Propranolol + Relaxation/Guided Imagery

Questionnaires BEHAVIORAL

Questionnaires completed at baseline, 2 months, and 4 months.

Also known as: Surveys

Propranolol + Relaxation/Guided Imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

Lyndon B. Johnson General Hospital (LBJ)

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Anxiety Disorders

Interventions

Propranolol; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Due to early termination, low accrual and lack of funding unable to determine the primary outcome.

Results Point of Contact

• Title: Lois M. Ramondetta, MD, Professor, Gynecologic Oncology & Reproductive Medicine
• Organization: UT MD Anderson Cancer Center

lramonde@mdanderson.org

713-745-0307

Study Officials

• Lois M. Ramondetta, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 18, 2013
• Study Start: September 11, 2013
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Locations

US (2)