A Combination Therapy for Cancer-Related Fatigue in Advanced Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Feasibility For Participants with Cancer-Related Fatigue (CRF)
研究概览
简要总结
This phase II/III trial studies how well physical activity with or without dexamethasone works in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body or has come back. Dexamethasone may decrease the body's immune response. Combining physical activity with dexamethasone may help to treat fatigue in patients with cancer.
详细描述
PRIMARY OBJECTIVES:
I. To test the hypotheses that patients with cancer-related fatigue (CRF) will be satisfied with the physical activity + dexamethasone (PA+ DEX) intervention, have adequate rates of adherence, and that PA+ DEX will be feasible for patients with CRF.
Ia. To determine if the combination of PA+ DEX is a feasible intervention for advanced cancer patients, as evidenced by an adherence rate to daily use of PA+ DEX greater than or equal to 75%.
Ib. To determine if patients are satisfied with PA+ DEX, based on more than 75% of patients indicating their satisfaction with PA+ DEX with a rating of "somewhat satisfied" or "completely satisfied."
SECONDARY OBJECTIVES:
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
- 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 locally advanced cancer (defined as metastatic or recurrent cancer or completed 2 lines of therapy) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
- •Presence of fatigue for at least 2 weeks
- •Normal cognition defined as Memorial Delirium Assessment Scale (MDAS) of =< 13/30 completed in person or via video conference
- •Hemoglobin > 8 g/L within 2 weeks of enrollment in the study
- •Zubrod performance status =< 2
- •Life expectancy of >= 4 months
- •Able to read, write, and speak English
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 of 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
- •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
- •Symptomatic cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
- •Patients currently on immunotherapy
- •Inability to comply with study protocol procedures
研究组 & 干预措施
Arm I (dexamethasone, exercise)
Patients receive dexamethasone PO BID for 7 days. Patients also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.
干预措施: Exercise Intervention (Behavioral)
Arm II (placebo, exercise)
Patients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.
干预措施: Exercise Intervention (Behavioral)
Arm I (dexamethasone, exercise)
Patients receive dexamethasone PO BID for 7 days. Patients also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.
干预措施: Dexamethasone (Drug)
Arm II (placebo, exercise)
Patients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.
干预措施: Placebo Administration (Other)
结局指标
主要结局
Feasibility For Participants with Cancer-Related Fatigue (CRF)
时间窗: Up to 1 month
Will be assessed by the proportion of participants completing the intervention. Will estimate 95% confidence intervals for the proportion of patients completing the intervention.
Adherence
时间窗: Up to 1 month
Will be calculated as the mean of the % of total prescribed strength training sessions and the % of total prescribed walking regimen minutes completed (exercise), and mean (across all patients) percentage of total prescribed pills taken (study medication) as detailed above. Will estimate 95% confidence intervals for the proportion of patients completing the intervention and the adherence rate.
Satisfaction
时间窗: Up to 1 month
Will estimate 95% confidence intervals for the proportion of patients with a satisfaction rating of "somewhat satisfied" or "completely satisfied."
次要结局
未报告次要终点