Effects of Physical Activity Plus Short Course of Dexamethasone for Cancer-Related Fatigue in Advanced Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29
研究概览
简要总结
This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.
详细描述
PRIMARY OBJECTIVES:
- To determine the feasibility, adherence, and satisfaction with physical activity (PA) plus dexamethasone (PA+ DEX).
SECONDARY OBJECTIVES:
I. To explore the preliminary efficacy of PA+ Hi Dex group (PA for 4 weeks plus high dose dexamethasone for 1 week) and PA + Lo Dex groups (PA for 4 weeks plus low dose dexamethasone for 1 week) on cancer-related fatigue (CRF) as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at the end of one week.
II. To explore the effects of PA+ Hi Dex on the various dimensions of CRF (Patient-Reported Outcomes Measurement Information System-Fatigue [PROMIS-F]), i.e., affective/emotional (Hospital Anxiety Depression Scale [HADS]); physical/behavioral (the Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Pittsburg Sleep Quality Index), physical activity and function (30 second sit-to stand test, six minute walk test) before and after treatment.
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
- •A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
- •The presence of fatigue for at least 2 weeks
- •Normal cognition
- •Hemoglobin > 8 g/L within 1 week of enrollment in the study
- •A life expectancy of >= 4 months
- •No evidence of significant anxiety or depression as determined by a total HADS scores of < 21
- •Definition of advanced cancer includes those patients who have metastatic or refractory disease according to their treating oncologist
- •Patients must be able to understand, read, write, and speak English or Spanish
排除标准
- •Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician
- •Reports a fall in the past 30 days
- •Uncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physician
- •Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
- •Will exclude patients with current, active peptic ulcer disease
- •Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm
- •Regular participation in moderate- or vigorous-intensity physical activity for >= 30 minutes at least 5 times a week and strength training for >= 2 days
- •Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
研究组 & 干预措施
Arm I (high-dose dexamethasone, physical activity)
Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Dexamethasone (Drug)
Arm I (high-dose dexamethasone, physical activity)
Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Exercise Intervention (Behavioral)
Arm I (high-dose dexamethasone, physical activity)
Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (high-dose dexamethasone, physical activity)
Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Quality-of-Life Assessment (Other)
Arm I (high-dose dexamethasone, physical activity)
Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Questionnaire Administration (Other)
Arm II (low dose dexamethasone, physical activity)
Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Dexamethasone (Drug)
Arm II (low dose dexamethasone, physical activity)
Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Exercise Intervention (Behavioral)
Arm II (low dose dexamethasone, physical activity)
Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (low dose dexamethasone, physical activity)
Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Quality-of-Life Assessment (Other)
Arm II (low dose dexamethasone, physical activity)
Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29
时间窗: Baseline, day 8, day 29
FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
次要结局
- Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total(Baseline, day 8, day 29)
- Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue(Baseline, day 8, day 29)
- Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score(Baseline, day 8, day 29)