Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.
The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.
详细描述
The main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.
The specific objectives are:
- To evaluate the baseline nutritional status of cancer patients undergoing elective surgery
- To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients
- To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status
- To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay
Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery.
Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female from all ethnicity
- •25 to 65 years
- •BMI not less than 18.0 kg/m²
- •Cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2
- •Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength.
排除标准
- •Patients who require enteral or parenteral feeding
- •Pregnant or lactating
- •On chemotherapy or radiotherapy
- •Total gastrectomy or ileostomy
- •Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia
- •On regular steroids prescription
结局指标
主要结局
Change in body weight
时间窗: Change from baseline body weight at 4 months
Anthropometry measurement
Change in body mass index (BMI)
时间窗: Change from baseline body mass index (BMI) at 4 months
Anthropometry measurement
Change in serum albumin level
时间窗: Change from baseline serum albumin level at 4 months
Serum albumin is an indicator of protein stores to assess nutritional status
Change in serum pre-albumin level
时间窗: Change from baseline serum pre-albumin level at 4 months
Serum pre-albumin is an indicator of protein stores to assess nutritional status
次要结局
- Change in handgrip force(Change from baseline handgrip force at 4 months)
- Length of hospital stay(Up to 5 days)
- Change in muscle mass(Change from baseline muscle mass at 4 months)
- Change in fat mass(Change from baseline fat mass at 4 months)
- Change in serum transferrin level(Change from baseline serum transferrin level at 4 months)
- Change in hemoglobin level(Change from baseline hemoglobin level at 4 months)
- Change in Interleukin-6 (IL-6)(Change from baseline Interleukin-6 (IL-6) at 4 months)
- Change in salivary cortisol level(Change from baseline salivary cortisol level at 4 months)
- Change in protein intake(Change from baseline protein intake at 4 months)
- Change in high sensitivity c-reactive protein (HsCRP) level(Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months)
- Change in energy intake(Change from baseline energy intake at 4 months)
- Change in Pittsburgh Sleep Quality Index (PSQI) scores(Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months)
- Presence of post-surgical complications(Change from baseline post-surgical complications at 3 months)
研究者
Winnie Chee
Principal Investigator
International Medical University