Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in cancer related fatigue
研究概览
简要总结
This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.
详细描述
PRIMARY OBJECTIVE:
I. To determine the effects of open labeled placebo one tablet twice a day (OLP) compared to waitlist control (WLC) for reducing cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale in fatigued advanced cancer patients at the end of one week.
SECONDARY OBJECTIVES:
I. To determine the preliminary efficacy open labeled placebo (OLP) and WLC on various fatigue dimensions - (Multidimensional Fatigue Symptom Inventory, MFSI-SF), depression (The Center for Epidemiologic Studies - Depression [CES-D]), cancer symptoms (Edmonton Symptom Assessment System [ESAS]), function and strength (six minute walk test, and 30-sec chair stand test), Global Symptom Evaluation (GSE), and quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]) in these advanced cancer patients.
II. To determine effects of OLP on fatigue symptom composite score (ESAS fatigue, pain and depression) at the end of 1st and 4th week.
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
- 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
- •Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors)
- •Presence of fatigue of >= 4/10 on Edmonton Symptom Assessment System (ESAS) Fatigue item (0-10 severity scale)
- •Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
- •Uncontrolled pain; patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry. Change in opioid dose after study entry is allowed
- •Patient must be 18 years of age or older. The questionnaires used in this study have been validated only in the adult population
- •Patient must be willing to engage in telephone follow up with research staff
- •Patient must have telephone access to be contacted by the research staff
- •Hemoglobin level of >= 8 g/dL. Patient may receive packed red blood cell (PRBC) transfusion so as to have hemoglobin level of >= 8 g/dL so at participate in the study
排除标准
- •Surgery, or pain relieving procedures within 2 weeks of entry into the study or during the study period
- •Patients with history of substance abuse (Cut down, Annoyed, Guilty, Eye opener [CAGE] >= 2+), cognitively impaired (MD Anderson Symptom [MDAS] > 7)
研究组 & 干预措施
Arm I (open labeled placebo)
Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.
干预措施: Quality-of-Life Assessment (Other)
Arm I (open labeled placebo)
Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.
干预措施: Placebo Administration (Other)
Arm I (open labeled placebo)
Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.
干预措施: Questionnaire Administration (Other)
Arm II (waiting list, open labeled placebo)
Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.
干预措施: Placebo Administration (Other)
Arm II (waiting list, open labeled placebo)
Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.
干预措施: Quality-of-Life Assessment (Other)
Arm II (waiting list, open labeled placebo)
Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.
干预措施: Questionnaire Administration (Other)
Arm II (waiting list, open labeled placebo)
Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.
干预措施: Waiting List (Other)
结局指标
主要结局
Change in cancer related fatigue
时间窗: Baseline up to 1 week
Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups.
次要结局
- Change in function strength(Baseline up to 4 weeks)
- Changes in cluster composite scores of sleep disturbance(Baseline up to 1 week)
- Changes in cluster composite scores of fatigue(Baseline up to 1 week)
- Incidence of adverse events(Up to 4 weeks)
- Change in quality of life (QOL)(Baseline up to 4 weeks)
- Changes in cluster composite scores of pain(Baseline up to 1 week)
- Changes in cluster composite scores of depression(Baseline up to 1 week)
- Adherence(Up to 4 weeks)
- Change in Global Symptom Evaluation (GSE)(Baseline up to 4 weeks)