Efficacy and Safety of Rapid-Onset Opioids for Exertional Dyspnea in Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT)
研究概览
简要总结
This phase II trial studies fentanyl buccal tablet or morphine to see how well it works compared to a placebo in controlling shortness of breath during or after physical activity in cancer patients. Fentanyl sublingual tablet and morphine are opioids normally used to control pain that may also help to prevent or control shortness of breath during or after physical activity in cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. To compare the effect of prophylactic fentanyl buccal tablet (FBT), morphine sulfate, and placebo on the increase in the intensity of exertional dyspnea (0-10 point modified Borg scale) measured before versus at the end of a shuttle walk test (SWT).
SECONDARY OBJECTIVES:
I. To compare the effects of prophylactic FBT, morphine sulfate, and placebo on SWT distance and dyspnea unpleasantness, average daily dyspnea (intensity and unpleasantness, oxygen cost diagram), personalized daily activity (ability to complete activity), personalized dyspnea response, symptom burden (Edmonton Symptom Assessment System [ESAS]), quality of life (EuroQol-5 Dimension-5 Level [EQ-5D-5L]), and dyspnea severity and functional impairment based on the Patient Reported Outcomes Measurement Information System (PROMIS) dyspnea instruments.
II. To explore the effects of prophylactic FBT, morphine sulfate, and placebo on neurocognitive function, addictive potential (Drug Effects Questionnaire), adverse effects (Common Terminology Criteria for Adverse Events [CTCAE], Patient-Reported Outcomes version of CTCAE [PRO-CTCAE]), and pattern of opioid use.
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, Care Provider, 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 with evidence of active disease
- •Dyspnea on exertion with an average intensity level ≥4/10 on a modified Borg scale
- •Outpatient at participating centers
- •Ambulatory and able to walk, with or without walking aid
- •On strong opioids with morphine equivalent daily dose (MEDD) of 60-400 mg for ≥1 wk (i.e. at least 4 out of 7 days), with stable (i.e. ±30%) regular dose over the last 3 d
- •Karnofsky performance status ≥40%
- •Age ≥18 yrs
- •Able to complete study assessments
- •Able to speak English or Spanish
- •Reside within 65 miles of participating centers or expected to visit MD Anderson in person at least once a month
排除标准
- •Dyspnea at rest ≥7/10 on modified Borg scale at enrollment
- •Supplemental oxygen requirement >6 L/min
- •Delirium (i.e. Memorial Delirium Assessment Scale ≥13)
- •History of unstable angina or myocardial infarction 1 mo prior to enrollment
- •Hemodynamic instability requiring hospitalization
- •History of substance use disorder or abnormal urinary drug screen within the past year, or at risk of opioid abuse as determined by Screener and Opioid Assessment for Patients with Pain (SOAPP14) ≥7
- •History of or known allergy to fentanyl or morphine sulfate
- •Using scheduled benzodiazepines at the time of enrollment and cannot stop during the study
- •Severe anemia (Hb <7 g/L) if documented in the last month and not corrected prior to study enrollment*
- •Bilirubin ≥5x upper limit of normal if documented in the last month and not lowered to <5x normal prior to enrollment*
- •Diagnosis of acute pulmonary embolism within past 2 wks
- •Diagnosis of pulmonary hypertension
- •Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 wks
- •Currently pregnant or breastfeeding
- •Unwilling to provide informed consent
研究组 & 干预措施
Group I (shuttle walk test, FBT)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FBT sublingually daily on days 6-19.
干预措施: Physical Performance Testing (Other)
Group I (shuttle walk test, FBT)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FBT sublingually daily on days 6-19.
干预措施: Quality-of-Life Assessment (Other)
Group I (shuttle walk test, FBT)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FBT sublingually daily on days 6-19.
干预措施: Questionnaire Administration (Other)
Group II (shuttle walk test, morphine)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.
干预措施: Physical Performance Testing (Other)
Group II (shuttle walk test, morphine)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.
干预措施: Quality-of-Life Assessment (Other)
Group II (shuttle walk test, morphine)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.
干预措施: Questionnaire Administration (Other)
Group III (shuttle walk test, placebo)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive placebo (sublingually or PO) daily on days 6-19.
干预措施: Physical Performance Testing (Other)
Group III (shuttle walk test, placebo)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive placebo (sublingually or PO) daily on days 6-19.
干预措施: Placebo Administration (Other)
Group III (shuttle walk test, placebo)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive placebo (sublingually or PO) daily on days 6-19.
干预措施: Quality-of-Life Assessment (Other)
Group III (shuttle walk test, placebo)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive placebo (sublingually or PO) daily on days 6-19.
干预措施: Questionnaire Administration (Other)
Group I (shuttle walk test, FBT)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FBT sublingually daily on days 6-19.
干预措施: Fentanyl Citrate Buccal Tablet (Drug)
Group II (shuttle walk test, morphine)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.
干预措施: Morphine (Drug)
结局指标
主要结局
Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT)
时间窗: Days 5, 8, 12, 15, and 19
Will first determine whether the three treatment groups are different; if so, will test the three pairwise comparisons with intention-to-treat analyses. Repeated-measures analysis of variance (ANOVA) will be implemented using linear mixed effects models with the difference in intervention period SWT modified Borg scale dyspnea intensity before and after SWT as the response variable and the treatment group and observation period SWT measures as predictor variables.
次要结局
- Dyspnea unpleasantness(Days 5, 8, 12, 15, and 19)
- Oxygen cost diagram(Days 1-19)
- Daily dyspnea intensity and unpleasantness(Days 1-19)
- Personalized daily activity(Days 1-4, 6-7, 9-11, 13-14, and 16-18)
- Symptom burden Questionnaires(Days 1-19)
- Neurocognitive function(Up to day 19)
- Frequency, severity, and interference of adverse effects(Up to day 19)
- Total opioid dose(Up to day 19)
- SWT distance(Days 5, 8, 12, 15, and 19)
- Quality of life Questionnaires(Days 1-19)
- Dyspnea severity and functional impairment(Day 1, 5, 12, 19)
- Addictive potential(Up to day 19)
- Number of rescue doses per day(Up to day 19)