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

• Status: Terminated
• Trial end date: 2020-08-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Adrenergic Agents; Propranolol

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.