NCT06890221招募中不适用
Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) in Breast Cancer Patients: a Double-Blinded Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Mean difference of phase angle after nutritional intervention
研究概览
简要总结
The goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. The main question it aims to answer is:
- Can perioperative nutrition interventions improve phase angle in relation to other bioimpedance parameters, handgrip strength and surgical outcomes in breast cancer population?
Researchers will compare oral nutritional supplement to a placebo to see if oral nutritional supplement can improve phase angle.
Participants will:
- Be randomized into either arm
- Take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively
- Have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed operable breast cancer
- •Aged 18 of years and above
- •Consented and scheduled for mastectomy
排除标准
- •On enteral supplementation prior to the study
- •Lactose intolerance
- •Pregnant or lactating
- •Previous history of gastrectomy or small bowel resection surgery
- •Advanced breast cancer staging, presence of pacemaker, decompensated liver disease, end stage renal failure, uncontrolled diabetes, on steroid therapy or complementary traditional medications
研究组 & 干预措施
Cohort A
Placebo Comparator
Placebo
干预措施: Placebo (Dietary Supplement)
Cohort B
Active Comparator
Oral nutrition supplement
干预措施: B-Crobes intake complete nutrition (Dietary Supplement)
结局指标
主要结局
Mean difference of phase angle after nutritional intervention
时间窗: From enrollment to 30 days post operation
To measure the mean difference of phase angle between groups after nutritional intervention
次要结局
- Changes in handgrip strength(From enrollment to 30 days post operation)
- Correlation of phase angle with bioimpedance analysis parameters(From enrollment to 30 days post operation)
- Potential factors associated with postoperative complications(From enrollment to 30 days post operation)
- Cutoff value of phase angle(From enrollment to 30 days post operation)
研究者
Soo Wai Yin
Medical Doctor
University of Malaya
研究点 (1)
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