A Pilot Open Label Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy Including Lenalidomide on Cancer Related Sleep Disturbances in Chronic Lymphocytic Leukemia (CLL) and Breast Cancer Patients Experiencing Clinically Significant Fatigue
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total Sleep Time as Measured by Polysomnography (PSG)
研究概览
简要总结
The goal of this clinical research study is to learn if treatments to kill cancer cells including lenalidomide and/or radiation therapy can help to control symptoms such as sleep problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast cancer.
详细描述
In this study, researchers are trying to learn if treatments to kill cancer cells such as lenalidomide and/or radiation therapy can also help to control sleep problems and fatigue in patients with CLL and/or breast cancer.
Study Procedures:
If you are found to be eligible to take part in this study, before you begin taking chemotherapy on Day 1, the following tests and procedures will be performed:
- Blood (about 2 tablespoons) will be drawn to learn about the relationship between changes in specific protein levels in the blood, your level of fatigue, and sleep problems.
- Your complete medical history will be recorded.
- You will have a physical exam.
- You will also complete 4 questionnaires that will ask you questions about your symptoms and your sleep patterns. They will take 20-30 minutes to complete in total.
From Day 1 through the end of 1st cycle (+/- 3 days), you will wear a watch that records your body movements. This is called an actigraph.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Describe fatigue as being present every day for most of day for a minimum of 2 weeks and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).
- •Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer receiving new cytotoxic or radiation therapy
- •Patients will be eligible to participate in this study if they rate sleep disturbance greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.
- •Have a MDAS of 13 or less.
- •Able to understand the description of the study and give written informed consent.
排除标准
- •Patients who are unable to complete the assessment measures or refuse to participate
- •Patients with known history of brain metastasis.
- •Patients with known history of sleep apnea.
研究组 & 干预措施
Sleep time
Assessment of patients with chronic lymphocytic leukemia (CLL) experience severe cancer related fatigue (CRF):
Lenalidomide + Actigraph + Questionnaire + Sleep Test
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Total Sleep Time as Measured by Polysomnography (PSG)
时间窗: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
Polysomnography (PSG) was done to measure the total sleep time in minutes. It was measured as a change in total sleep time between the before and after 1st cycle of treatment with Lenalidomide.
次要结局
- ECOG Performance Status(before and after first cycle of Lenalidomide treatment, up to 8 weeks)
- The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score(before and after 1st cycle of Lenalidomide treatment, up to 8 weeks)
- Epwort Sleep Scale(before and after 1st cycle of Lenalidomide treatment, up to 8 weeks)