The Effect of Dexamethasone on Symptoms 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
- 132
- 试验地点
- 4
- 主要终点
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
研究概览
简要总结
The goal of this clinical research study is to learn if dexamethasone can help to control symptoms such as fatigue, pain, nausea, weight loss, loss of appetite, sleep problems, and/or depression in patients with advanced cancer.
详细描述
Dexamethasone decreases inflammation and also suppresses the immune system.
If you are found to be eligible for this study, you will be randomly assigned (as in the toss of a coin) to receive either dexamethasone or a placebo by mouth in the morning and at night with food every day for 14 days. A placebo is a substance that looks like the study drug but which has no active ingredients. You will have an equal chance of being placed in either of the 2 groups. You, the medical staff, and researchers will not know to which group you have been assigned.
Beginning on Day 15 [± 3 days], regardless of if you were assigned to the dexamethasone or placebo group during the first 14 days, you will begin receiving the dexamethasone. On Days 15-21, you will receive dexamethasone 2 times a day. On Days 22-28 you will continue to take dexamethasone 2 times a day, but it will be at a lower dose level.
If you develop intolerable side effects while on this study, the medication will be stopped and you will be removed from the study.
You will be asked to return to the outpatient clinic on Days 8 [± 3 days], 15 [± 3 days] , 22 [± 3 days], and 29 [± 3 days] to answer a questionnaire about your cancer diagnosis, the medication you are taking, and the symptoms you are having (for example, pain, fatigue, nausea, appetite problems, sleep problems, depression, and your overall sense of well-being). The questionnaire will take approximately 30 minutes to complete. Blood (about 1 tablespoon) will be drawn to measure protein levels and to check the iron level in your blood. If you are unable to return to the clinic on days 8, 15, 22, or 29; the assessments will be done by the research nurse by phone; the blood work will not be done.
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
- •Present with 3 or more symptoms during the last 24 hours (Pain, fatigue, chronic nausea, and anorexia/cachexia, sleep problems, depression or poor appetite), with an average intensity of >/= 4 on a 0-10 scale, in which 0= no symptom, and 10= worst possible symptom,
- •No clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of 13 or less at baseline
- •Must be 18 years of older
- •No longer a candidate for aggressive anticancer therapy-such as receptor blockers (Iressa, etc.) Patients on oral or palliative chemotherapy are eligible for study if approved by primary oncologist prior to inclusion. Patients who are receiving IV chemotherapy are eligible for study if approved by primary oncologist and they have completed 1st line of chemotherapy and are deemed stable by primary oncologist. The PI of this study will obtain and document approval from the primary oncologist in the patient's study documents.
- •Life expectancy =/> 30 days
- •Must understand and sign written informed consent
- •Patients on topical, or inhaled corticosteroids are eligible for study. If patients have been on oral corticosteroids for </= 7 days prior to inclusion of study they are eligible for study.
排除标准
- •Allergy to Dexamethasone
- •Inability to complete the baseline assessment forms
- •Patients currently taking Megestrol, and not off drug for > 7 days
- •Anemia as defined as < 9 hemoglobin
- •Known history of human immunodeficiency virus (HIV)
- •Neutropenia as defined by an absolute neutrophil count (ANC) of < 1500 cells/mm
- •Patients with a history of diabetes will be excluded.
- •All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks
- •Those who are currently receiving oral corticosteroid therapy or who have been on corticosteroid therapy >/= 8 days prior to study inclusion
- •Sepsis and/or acute, chronic, or ongoing infections
研究组 & 干预措施
Placebo
Placebo by mouth (PO) twice daily for 14 days.
On day 15 [ ± 3 days], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone tapered to 2 mg orally twice a day between days 22 to 28.
干预措施: Placebo (Drug)
Placebo
Placebo by mouth (PO) twice daily for 14 days.
On day 15 [ ± 3 days], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone tapered to 2 mg orally twice a day between days 22 to 28.
干预措施: Dexamethasone (Drug)
Dexamethasone
Dexamethasone 4 mg orally two times a day for 14 days.
On day 15 [ ± 3 days], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone tapered to 2 mg orally twice a day between days 22 to 28.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
时间窗: Baseline to Day 15
FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. It was measured as change in symptom score from Baseline to Day 15.
次要结局
- Hospital Anxiety and Depression Scale (HADS) Anxiety(Baseline to day 15)
- Edmonton Symptom Assessment System (ESAS) Nausea(Baseline to Day 15)
- Edmonton Symptom Assessment System (ESAS) Pain(Baseline to day 15)
- Edmonton Symptom Assessment System (ESAS) Appetite(Baseline to day 15)
- Hospital Anxiety and Depression Scale (HADS) Depression(Baseline to day 15)