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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Proportion of Patients Completing Symptom Inventories
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 >
- •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)
- •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.
研究组 & 干预措施
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.
干预措施: Propranolol (Drug)
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.
干预措施: Diary (Behavioral)
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.
干预措施: Relaxation Audio Recording (Behavioral)
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.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Proportion of Patients Completing Symptom Inventories
时间窗: 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).
次要结局
未报告次要终点