A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity
研究概览
简要总结
This phase II trial studies how well dexamethasone works in controlling dyspnea in patients with cancer. Dexamethasone may help control dyspnea (shortness of breath) and improve lung function and quality of life in cancer patients.
详细描述
PRIMARY OBJECTIVES:
I. Compare the intensity of dyspnea (numeric rating scale [NRS]) in the dexamethasone arm with that in the placebo arm at week 1.
SECONDARY OBJECTIVES:
I. Compare the effects of dexamethasone with those of placebo in terms of personalized dyspnea response (based on a personalized dyspnea goal), unpleasantness of dyspnea, other symptoms, health-related quality of life, respiratory physiologic function, and adverse effects at week 1 and week 2, as well as the intensity of dyspnea at week 2.
II. Identify predictive markers of dyspnea response to dexamethasone.
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
- Double (Participant, Investigator)
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
- •Diagnosis of cancer.
- •Dyspnea with an average intensity >= 4 on the dyspnea NRS (range 0-10) over the past week.
- •Radiologic suspicion of thoracic involvement, such as primary or metastatic lung cancer, lymphangitic carcinomatosis, airway infiltration, lymphadenopathy, pleural or chest wall invasion.
- •Seen at an outpatient clinic at MD Anderson Cancer Center or Lyndon B. Johnson (LBJ) Hospital General Oncology Clinic.
- •Able to communicate in English or Spanish.
- •Karnofsky performance status >= 30%.
排除标准
- •Delirium (i.e., score > 13 on the Memorial Delirium Assessment Scale; range 1-30).
- •Oxygen saturation < 90% despite supplemental oxygen > 6 L/minute.
- •Previous allergic reactions to dexamethasone.
- •Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin.
- •Postsurgical open wound that has not healed at the time of enrollment.
- •Any infection requiring antibiotics at the time of study enrollment.
- •Major surgery within the past 2 weeks.
- •Megestrol use at the time of study enrollment.
- •Neutropenia (absolute neutrophil count < 1.0 x 10^9/L) at the time of study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
- •Currently receiving or expected to start cytotoxic chemotherapy or immunotherapy within 1 week of study enrollment and additional dexamethasone cannot be used concurrently as per attending oncologist.
- •Severe anemia (hemoglobin < 8 g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
- •Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment.
- •Heart failure exacerbation at the time of study enrollment.
- •Expected to undergo therapeutic thoracentesis in the next 2 weeks.
- •High anxiety score (>= 15/21) on the Hospital Anxiety and Depression Scale (HADS).
- •Chronic systemic corticosteroid use (> 14 days) at the time of study enrollment.
- •Any expected corticosteroid use during study enrollment at higher doses than will be used in this study.
研究组 & 干预措施
Group II (placebo, dexamethasone)
Patients receive placebo PO BID on days 1-14 and dexamethasone PO BID on days 15-28 in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo (Other)
Group II (placebo, dexamethasone)
Patients receive placebo PO BID on days 1-14 and dexamethasone PO BID on days 15-28 in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group I (dexamethasone)
Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group I (dexamethasone)
Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.
干预措施: Dexamethasone (Drug)
Group II (placebo, dexamethasone)
Patients receive placebo PO BID on days 1-14 and dexamethasone PO BID on days 15-28 in the absence of disease progression or unacceptable toxicity.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity
时间窗: Baseline and Day 7
The average dyspnea intensity over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis.
次要结局
- Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness(Baseline and Day 7)
- Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7(Baseline and Day 7)
- Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7(Baseline and Day 7)
- Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14(Baseline and Day 14)
- Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity(Baseline and Day 14)
- Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness(Baseline and Day 14)
- Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14(Baseline and Day 14)