The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- AUC Change in Level of IL-6
研究概览
简要总结
This randomized clinical trial uses an inactive typhoid vaccine to briefly stimulate an immune response in patients with stage I-IIIA breast cancer who received primary cancer treatment and studies whether patients' fitness levels affect how their bodies handle a challenge to their immune system. A vaccine is a substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms such as bacteria or viruses. Immune responses may cause excess inflammation in the body and behavioral changes, such as depression, fatigue, pain, and problems with thinking and reasoning. Studying immune responses in patients with breast cancer who have undergone primary cancer treatment may help doctors learn whether physical fitness can protect the body from effects of immune system stress and whether it may be able to reduce health problems in patients with breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the relationships between cardiorespiratory fitness and inflammatory and behavioral responses (negative mood, fatigue, pain, and cognitive problems) to typhoid vaccine in breast cancer survivors.
II. To determine the effects of age and depressive symptoms on inflammatory and behavioral responses to typhoid vaccine and placebo.
III. To assess the ability of cardiorespiratory fitness to moderate age- and depression-related responses to typhoid vaccine.
OUTLINE: Patients are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have been diagnosed with stage I-IIIA breast cancer will be recruited 1-10 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors)
- •All women will be postmenopausal
排除标准
- •A prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)
- •Alcohol or drug abuse
- •Medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions
- •Women who have received a typhoid vaccine within the last three years
结局指标
主要结局
AUC Change in Level of IL-6
时间窗: Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine
AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.
次要结局
- AUC Change in Fatigue(baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine)
- AUC Change in Pain(baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine)
研究者
Janice Kiecolt-Glaser
Principal Investigator
Ohio State University Comprehensive Cancer Center