A Randomized Clinical Trial of Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in Appetite as Measured by ESAS
研究概览
简要总结
The goal of this clinical research study is to evaluate the effectiveness of melatonin for the management of poor appetite and weight loss in advanced cancer patients. The effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved appetite, and side effects will also be evaluated.
详细描述
Melatonin is a hormone that is made by the part of the brain called the pineal gland and may help in letting your body know when it is time to go to sleep and when it is time to wake up. The researchers feel melatonin might help to improve your appetite, improve your overall sense of well-being, and maintain your current weight.
If you are found to be eligible to take part in this study, you will see a nutritionist at the first (baseline) visit. The nutritionist will measure the amount of calories you consume. You will be asked to report all food and drinks you have had in a 3-day period. If you are unable to remember what you have eaten and drunk in the last 3 days, you will be asked by the nutritionist to list all the food and drinks you have had within the last 24 hours.
Your arm muscle diameter and your skin fold below your shoulder blade will be measured on the arm you don't normally use to write with. This is to determine your body fat, lean mass and water content of your body.
Your resting energy expenditure will be measured. You will be asked to wear a breathing mask and to blow into a tube. This will allow your breath to be analyzed, to measure how many calories your body is using while you are at rest.
Blood (about 1-2 tablespoons) will be drawn for tests to make sure there are no other treatable causes for your weight loss.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with solid gastrointestinal tumors or lung cancer patients referred to palliative care and a 5% or more involuntary weight loss within the last 6 months with anorexia (>3 on visual analog scale such as ESAS)
- •Greater than or equal to 18 years of age
- •Karnofsky score of 40 or higher
- •Patient has the ability to maintain oral food intake during the study period
- •If patients who have persistent anorexia/cachexia and are currently taking Megace, corticosteroids, non-steroidal anti-inflammatories (NSAID's), or thalidomide, they should be on the medication at least 2 weeks prior to study inclusion
- •Ability to sign informed consent and understand study procedures
- •Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study other than melatonin if they have been on stable dose for at least 2 weeks
- •Negative pregnancy testing in women with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- •Patients who cannot take Megace because of past history or elevated risk of DVT, adrenal insufficiency, impotence, hyperglycemia, CHF, menorrhagia, etc.
- •Patients who have persistent anorexia/cachexia after treatment with Megace has failed
排除标准
- •Patients who have dementia or delirium on entry into study as determined by the palliative care specialist using DSM-IV-criteria
- •Patients who are currently taking melatonin
- •Inability to take oral food during the study period
- •Unstable secondary cachexia caused by nausea, diarrhea, taste abnormalities, mucositis, constipation, dysphagia, or clinical depression prior to study inclusion. These symptoms should be resolved or stable for >/= 2 weeks at the time of inclusion into study as determined by the Palliative Care Specialist.
- •Inability to sign informed consent or understand study procedures
- •Karnofsky score of < 40
- •Patients < 18 years of age
- •Patients with </= 5% involuntary weight loss within the last 6 months and anorexia of < 3 on ESAS
- •Patients who are on complementary therapies containing melatonin or on medications for < 2 weeks and not on stable dose
- •Patients who have a cortisol level of </= 4.3 mg/dL at baseline will be excluded, unless they are on replacement corticosteroids.
- •Patients with a TSH of </= 0.50 or >/= 10 mcL/mL at baseline will be excluded
- •Pregnant females or females who are lactating/nursing
研究组 & 干预措施
Melatonin
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
干预措施: Melatonin (Drug)
Placebo
20 mg of Placebo before going to sleep at night for a period of 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Appetite as Measured by ESAS
时间窗: Baseline and at 4 weeks
Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation \[± 3 days\] to 4 week evaluation \[± 3 days\], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.
次要结局
未报告次要终点