The Effects of Thalidomide on Symptom Clusters
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS)
研究概览
简要总结
The goal of this clinical research study is to learn if thalidomide can improve symptoms such as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with advanced cancer.
详细描述
Thalidomide is designed to change the immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will be asked about your cancer diagnosis, the drugs you are taking, and the symptoms you are having (for example, pain, fatigue, anxiety, depression, poor appetite, and sleep problems). Blood (about 2 tablespoons) will be drawn to measure protein levels in your blood.
Women who are able to have children must have a negative blood (about 1 tablespoon) pregnancy test 24 hours before beginning to receive thalidomide.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in toss of a coin) to one of 2 groups. You will have an equal chance of being placed in either of the 2 groups. You, the medical staff, and researchers will not know which group you have been assigned to.
Participants in Group 1, who are not on chemotherapy, will take 2 thalidomide capsules, by mouth, once a day for 14 days. Participants in Group 1, who are on chemotherapy, will take 1 thalidomide capsule, by mouth, once a day for 7 days, and then 2 thalidomide capsules, by mouth, once a day for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Have weight loss of > 5% within the last 6 months
- •Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom.
- •Describe the symptoms as being present every day for a minimum of 2 weeks.
- •Have no clinical evidence of cognitive failure
- •Must be 18 years or older.
- •Expect to live at least >/= 4 weeks
- •Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA criteria for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months.
- •Understand and sign written informed consent.
- •Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea.
- •Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety]
- •Patient's Absolute neutrophil count (ANC) at time of study enrollment is >/= 750 mm (to be drawn within 14 days prior to registration)
- •May be on chemotherapy if at a stable dose. Targeted therapies or hormone therapies are permitted once patient has completed two weeks of treatment.
排除标准
- •Have major contraindication to thalidomide, i.e. hypersensitivity.
- •Present with National Cancer Institute (NCI) Common Toxicity Criteria Grade 3 or more peripheral neuropathy.
- •Are not able to complete the baseline assessment forms.
- •Are pregnant or lactating.
- •Patients with clinical history of seizures
- •Patients with an ANC of </= 750 at time of study enrollment will be excluded (to be drawn within 14 days prior to registration).
- •Patients with a history of Acquired Immune Deficiency Syndrome (AIDS), systemic lupus erythematous, or renal failure as defined by a serum creatinine of > 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration).
- •Patients on Revlimid (lenalidomide).
- •Patients on investigational chemotherapy/agents.
研究组 & 干预措施
Group 1: Thalidomide
100 mg capsules orally, once a day for 14 days
干预措施: Thalidomide (Drug)
Group 2: Placebo
Two placebo capsules orally, once a day for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS)
时间窗: Baseline to Day 29
ESAS assessment of appetite (symptom) 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. Evaluated at baseline \[± 3 days\], 2 weeks\[± 3 days\] and 4 weeks \[± 3 days\]
次要结局
- Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety)(Baseline to Day 29)
- Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression)(Baseline to Day 29)
- Change in Body Composition as Measured by Body Mass Index (BMI)(Baseline to Day 29)
- Functional Assessment of Anorexia/Cachexia Therapy (FAACT)(Baseline to Day 29)
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Baseline to Day 29)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline to Day 29)
- Change in Serum Cytokines and Receptors(Baseline to Day 15)