A Prospective Multicenter Randomized Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer. Peri-Nutri
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
This is a multicenter, unblinded, randomized study. The aim of this study is to research whether preoperative and postoperative oral nutritional supplement (ONS) (Resource 2.5 Compact/fibre compact) used at least 2 weeks prior the surgery and 10 days after surgery can improve the nutritional status of a colon cancer patient and reduce number of complications. The aim is also to investigate whether the oral nutritional support can shorten the hospital stay and improve the patients´ quality of life. The aim is also to find out whether the oral nutritional support can reduce 90-day mortality and improve disease free and overall survival.
Consecutive patients diagnosed with primary adenocarcinoma of the colon who are considered for radical surgical procedure are enrolled in this study provided that the inclusion criteria are filled.
Patients in the intervention group start oral nutritional support (ONS)2 portions a day for about 2 weeks prior to the operation starting at the time of randomization and continue ONS 10 days after the operation. Control group will continue with their regular diet without ONS until the operation. Both groups keep a food diary for 4 days right after the randomization and both one month and three months after the operation to assess the energy and nutrient intakes.
Laboratory markers, NRS 2002, quality of life questionnaire, exercise questionnaire, bioelectrical impedance analysis (BIA) and handgrip strength as well as body composition on computer tomography scan are assessed prior to any treatment or supplement in order to estimate the patients' well-being and nutritional status prior to surgical operation. Laboratory parameters and QoL questionnaire are repeated right before the operation on admission to hospital as well as about 30 and 90 days after the operation in addition to BIA, handgrip strength to assess the effect of nutritional support. Data on complications, infections, length of stay in the hospital and mortality are collected.
Another arm in this research is to discover more information on biological markers in colon cancer and cancer related malnutrition thus providing targets for future treatment and prognostic predictors. Tissue samples are collected during this research at the surgery.
详细描述
The hypothesis in this study are:
- Perioperative ONS decreases surgery related morbidity
- Perioperative ONS increases the quality of life after surgery
- Perioperative ONS decreases the length of stay in institutional care
- Perioperative ONS decreases 90-day mortality and improve 5-year survival
- Perioperative ONS benefits the patients to tolerate the adjuvant chemotherapy with less side effects
- Perioperative ONS protects patients from postoperative nutritional depletion
Primary end point is to investigate whether the preoperative oral nutritional support decreases the number of complications during the 30-day follow up after the surgery. Secondary end points are to study the effect of oral nutritional support on quality of life after surgery, length of hospital stay, disease free and overall survival.
Randomization:
Patients having a surgery for adenocarcinoma of the colon are randomized on their preoperative visit in the outpatient clinic about 2-3 weeks prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18 years or older
- •Primary colon adenocarcinoma
- •Curative operation is possible
- •Patient has a life expectancy of at least 12 months
- •Patient signs the informed consent and agrees to attend all study visits
排除标准
- •Recurrent colon adenocarcinoma
- •Metastatic disease
- •Cancer that will require multiorgan resection
- •Pregnant or suspected pregnancy
- •Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 5).
- •Patients with concurrent or previous malignant tumors within 5 years before the study enrollment
- •Patient undergoing emergency procedures
- •Liver dysfunction, child pugh B or worse
- •NRS score <2 or >5
- •BMI under 18.5
- •Weight loss 15% or more past 6 months
- •Serum albumin less than 30 without liver or renal dysfunction
- •Chronic malnutrition: short bowel syndrome, previous gastrectomy, pancreatic dysfunction
- •Language barrier or other reasons why informed consent is not possible
结局指标
主要结局
Postoperative complications
时间窗: complications are studied in every patients 30 days after operation
Primary end point is to investigate whether the pre and postoperative oral nutritional support decreases the number of complications during the 30-day follow up after the surgery
次要结局
- Nutrition and Quality of life(5-year)
- Disease free and overall survival(5-year)
- 90-day mortality(90 days)
- Hospital stay(90 days)