Preliminary Study to Explore the Effects of Mirtazapine on Appetite in Advanced Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Comparison of ESAS scores in Appetite
研究概览
简要总结
Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days).
Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days)
Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days)
Other Objectives:
To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days).
To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).
详细描述
Mirtazapine is a drug that is used to treat clinical depression. It is designed to cause hormones ("chemical messengers" such as norepinephrine and serotonin) to be released in the brain, while blocking certain molecules that cause nausea, nervousness, headache, insomnia, diarrhea, and lowered sex drive. The release of these hormones may provide proper hormonal balance in the brain, which may increase appetite and weight.
Before you can start treatment on this study, you will have "screening tests." These tests will help the study doctor decide if you are eligible to take part in this study. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will be asked to complete 5 questionnaires that will ask about your diagnosis, the medication you are taking, how you have been feeling (such as tense or "wound up"), and any symptoms you may be having (such as pain, poor appetite, weight loss, fatigue, nausea, sleep problems, and depression), and times you have usually gone to bed during the past month. In total, these questionnaires will take about 40 minutes to complete. Women who are able to have children must have a negative urine pregnancy test.
If you are not found to be eligible to take part in this study, you will be provided with a referral to a palliative care doctor who will check your symptoms and plan the appropriate treatment.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. You will have an equal chance of being in 1 of the 2 groups. Neither you nor your doctor will know which treatment group you are assigned to. However, in the event of an emergency, for your safety your doctor will be informed about what treatment you are receiving.
Participants in one group will take a specified dose of mirtazapine (with or without food) at bedtime on Days 1-15. On Day 15, you will return to the clinic to repeat the same tests that you had during the screening visit and to be checked for any side effects you may have experienced. You will get 2 more prescriptions (2 different doses--a lesser dose and a greater dose) for mirtazapine. You will then take a lesser dose of mirtazapine (with or without food) for 7 days. During Week 3, you will take the greater dose of mirtazapine for another 7 days until Day 29.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS.
- •Patients > 18 years of age
- •Karnofsky Performance score of > 40 at time of inclusion into study
- •Ability to provide informed consent and comply with study procedures
- •Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/- 3 days), 8 (+/- 3 days), 16 ( +/- 3 days), and 22 (+/- 3 days) and return to outpatient clinic for evaluation on days 15 (+/- 3 days), and 29 (+/- 3 days).
- •Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment.
- •For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist
- •Drowsiness of </= 4/10 on ESAS at baseline due to known potential sedating effects of Mirtazapine
- •Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study (with the permission of their Attending MD) if they have been on stable dose for at least 2 weeks.
- •Patients who are on stable doses of antidepressants for at least 2 months.
排除标准
- •Patients who have known dementia or delirium at time of enrollment as determined by a physician.
- •Known hypersensitivity to any ingredient of Mirtazapine
- •Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting
- •Ongoing use of tube feeding or parenteral nutrition
- •Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment.
- •Pregnancy or lactation or unwillingness to use contraceptives
- •A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of > 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation.
- •Patients on chronic use of benzodiazepines are excluded
研究组 & 干预措施
Mirtazapine
Mirtazapine 15 mg by mouth (PO) daily for 15 days; Day 22-29, increased to 30 mg PO daily.
干预措施: Mirtazapine (Drug)
Placebo
One placebo tablet by mouth daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of ESAS scores in Appetite
时间窗: Baseline, and on days (+/-3) 15 and 28
Primary analysis is a comparison of the difference scores in appetite between baseline and 15 days in the two groups. 2-sample t test used to compare differences between groups or a nonparametric test such as the Wilcoxon test if the data are non-normally distributed. A difference of 2 or more in change scores considered to be clinically meaningful.
次要结局
- Insomnia (as measured by Pittsburgh Sleep Quality Index)(On day 15 ( +/- 3 days), and day 29 ( +/- 3 days))