Role of Peri-operative Immunonutrition in Cancers of the Higher Aero-digestive Tract
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Rate of infectious complication
研究概览
简要总结
RATIONALE: It is not yet known which regimen of enteral nutrition is more effective in preventing infections in patients undergoing surgery for cancer of the upper aerodigestive tract.
PURPOSE: This randomized phase III trial is comparing three nutrition regimens in treating patients with cancer of the upper aerodigestive tract.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of immunonutrition (IMPACT®) in patients with de novo cancer of the upper aerodigestive tract.
Secondary
- Determine the best time to initiate treatment.
- Compare the intermediate duration of treatment.
- Compare nutritional parameters.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of de novo cancer of the upper aerodigestive tract, including the following:
- •Oral cavity
- •Oropharynx
- •Hypopharynx
- •Planned surgical excision of tumors with opening of the mucous membranes, with or without immediate reconstruction by myocutaneous pedicle flap or free-bone graft
- •Planned adjuvant enteral nutritional regimen lasting at least 7 days post-operatively
- •PATIENT CHARACTERISTICS:
- •ANC > 1.8 x 10^9/L
- •Hemoglobin > 9 g/dL
- •Transaminases ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 3 times ULN
- •Creatinine 70-250 μmol/L
- •Urea ≤ 1.5 times ULN
- •Glucose < 1.5 g/L
- •Sodium < 145 mmol/L
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No psychological, social, geographical, or familial reasons prohibiting follow-up
- •No insulin-dependent diabetes
- •No severe psychiatric illness
- •PRIOR CONCURRENT THERAPY:
- •No head and neck surgery for cancer within the past year
- •No prior oral components of immunonutrition
- •No prior neoadjuvant chemotherapy
- •No prior radiotherapy to head and neck
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive standard oral or enteral nutrition (IMPACT® placebo) over 7 days prior to surgery and over 7 days after surgery.
干预措施: placebo (Other)
Arm II
Patients receive oral or enteral neoadjuvant IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant standard nutrition (IMPACT® placebo) over 7 days after surgery.
干预措施: therapeutic nutritional supplementation (Dietary Supplement)
Arm II
Patients receive oral or enteral neoadjuvant IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant standard nutrition (IMPACT® placebo) over 7 days after surgery.
干预措施: placebo (Other)
Arm III
Patients receive oral or enteral IMPACT® nutrition over 7 days prior to surgery and enteral adjuvant IMPACT® nutrition over 7 days after surgery.
干预措施: therapeutic nutritional supplementation (Dietary Supplement)
结局指标
主要结局
Rate of infectious complication
时间窗: 1 year
次要结局
未报告次要终点