Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in fatigue as measured by the fatigue symptom inventory (FSI)
研究概览
简要总结
RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer.
PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer.
详细描述
OBJECTIVES:
- Determine the association between the body's immune system and energy, sleep, mood, and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer.
- Determine whether treatment with infliximab affects energy and immune function in these patients.
OUTLINE: Patients receive infliximab IV over 2 hours.
Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms, including mood, pain, and sleep.
After completion of study treatment, patients are followed at 2 weeks and then monthly for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who report elevated fatigue following cancer diagnosis and treatment
排除标准
- •Women who have medical conditions that may affect the immune system or are associated with baseline fatigue syndrome, and/or who use medications that affect the immune system or fatigue.
- •Women with major affective disorders and those with sleep or pain disorders.
- •Presence of medical conditions that may but subject at undue risk for experimental procedures.
- •Chronic or recurring infections, symptoms of chronic heart failure, demyelinating disorders, and those taking immunosuppressive medications.
- •Neoplastic disease other than primary breast cancer
- •Compromised cardiovascular function
- •Insulin-dependent diabetes
- •Neurological disorder
- •Peripheral neuropathy
- •Pregnancy
- •Use of psychotropic medications within 2 weeks of screening
- •Abnormal screening laboratory findings (i.e., creatinine > 1.4mg%; anemia; abnormal thyroid hormone; hematuria; elevated liver function tests, low protein or albumin; fasting glucose >120mg%; elevated FTI or TSH; positive TB screening, HIV screening or hepatitis C).
结局指标
主要结局
Change in fatigue as measured by the fatigue symptom inventory (FSI)
时间窗: At baseline and after completion of study treatment, 4 years
Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI)
时间窗: At baseline and after completion of study treatment, 4 years
次要结局
- Change in proinflammatory cytokines as measured by interleukin 6 value(At baseline and after completion of study treatment, 4 years)
- Change in proinflammatory cytokines as measured by tumor necrosis factor(At baseline and after completion of study treatment, 4 years)
- Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value(At baseline and after completion of study treatment, 4 years)