Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Mean Change in interleukin 6 (IL6)
研究概览
简要总结
Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a positive influence on chemotherapy response and 2) preserve or improve skeletal muscle, thus preventing cancer cachexia. Furthermore, we believe that the neoadjuvant treatment period could be a window of opportunity to optimize patient's nutritional status before surgery, which until now has been under used.
Bearing in mind that nutritional interventions may also influence IL-6, our hypothesis is that a Combined Exercise and Dietary Intervention (CEDI) may induce positive alterations in cytokine profile and increase NK cell infiltration of the tumor in gastric and pancreatic cancer patients submitted to neo-adjuvant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy,
- •age higher than 40 years and lower than 80 years,
- •ECOG (Eastern Cooperative Oncology Group) functional status: 0-2,
- •sedentary/low physical activity level.
排除标准
- •life expectancy less than 12 months at inclusion,
- •chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer,
- •metastatic disease,
- •chronic anti-inflammatory medication use,
- •known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis)
- •cardiovascular, respiratory or musculoskeletal or joint problems that preclude moderate physical activity.
研究组 & 干预措施
Control
Standard Care
干预措施: Standard Care (Behavioral)
Combined Exercise and Dietary Intervention
Intervention aimed at conveying a supervised combined moderate aerobic and resistance training, once a week with a duration of 40-60 minutes plus daily home exercise, personalized according to patients' age and functional status. Dietary intervention aimed at a one-on-one nutritional counseling. In the first visit a dietary plan is designed and one daily oral nutritional supplement (Fortimel Compact®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake.
干预措施: Combined Exercise and Dietary Intervention (CEDI) (Behavioral)
结局指标
主要结局
Mean Change in interleukin 6 (IL6)
时间窗: 8 weeks
IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI)
次要结局
- Change in Immune cell infiltration profile on tumor specimen(8 weeks)
- Change in skeletal muscle(8 weeks)
研究者
Sónia Velho
Nutricionist
Hospital Beatriz Ângelo