Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy: A Study Protocol for A Single Blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
Esophagus cancer patients are at risk for malnourishment. Feeding jejunostomy is used in advanced esophagus cancer patients in order to support and supplement the patient's nutrition needs. In dumping syndrome, the food is rapidly introduced into the intestine at a rate that is faster than normal, it is associated with both digestive system and vasoactive symptoms. Dumping syndrome has an association with both esophagus cancer patients and feeding jejunostomy. In the mid and long term, dumping syndrome is an important issue that contributes to the risk of malnourishment in advanced esophagus cancer patients. Acupuncture effect on digestive symptoms was widely investigated with effective abilities to regulate and reduce digestive symptoms. Acupuncture is also considered a safe intervention for cancer patients.
A total of 60 advanced esophageal cancer patients will be divided into two equal groups, the intervention group (n=30) and the control groups (n=30). Patients in the Intervention group will receive acupuncture using the following acupoints: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) liv 3 (Taichung). Patients and assessors will be blind to trial allocation. The patients in the Control group will receive shallow acupuncture on 12 non-acupoints (sham points). Both groups will receive acupuncture twice a week for 6 weeks. The main outcome measurements are body weight, BMI, the Sigstad's score and the Arts' dumping questionnaire, 3 and 6 months mortality.
详细描述
The direct effect of acupuncture on dumping syndrome was not previously well investigated. The goal of this randomized control clinical trial is to investigate the effect of acupuncture on dumping syndrome in esophagus cancer patients with jejunostomy tube feeding. We hypothesize that acupuncture will have a regulatory effect on dumping syndrome.
This research will investigate a possible cooperation and integration approach of both western and Chinese medicine in esophagus cancer treatment. In this integration, each treatment method focus on its strength (western medicine in tumor treatment and Chinese medicine in digestion symptoms) in order to improve the patient's condition and quality of life. This research will shed more light on the effectiveness of acupuncture as an intervention on both esophagus cancer patients and dumping syndrome. In case that the study findings will be in favor of acupuncture, it will provide a valuable, low cost supportive therapeutic option for advanced esophagus cancer patients with dumping syndrome.
This study will be conducted in the china medical university hospital in Taichung City, Taiwan, department of chest surgery. The study will be initiated after IRB approval and will be concluded until January 2024. Informed consent will be obtained prior to patient's enrollment. The 2 groups are an intervention group and a control group.
A total of 60 esophagus cancer patients with feeding jejunostomy from china medical hospital from the department of chest surgery. will be divided equally to 30 patients in each group after meeting the study inclusion criteria and informed consent.
60 patients from the china medical university will be divided into 2 groups. In both the ACU group and CON group, A qualified acupuncture doctor with at least 2 years of clinical experience will provide the intervention sessions on both groups. The acupuncture frequency will be 2 times a week for 6 weeks in both groups. Both groups will also receive routine western medicine treatments.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced esophageal cancer
- •Post feeding jejunostomy
- •Plan of CCRT for esophageal cancer
排除标准
- •Acute infection
- •Unstable vital signs
- •Other medical conditions which would affect nutrition status
结局指标
主要结局
Body Weight
时间窗: week6
Unit: kg
Body Height
时间窗: week6
Unit: cm
Body Mass Index
时间窗: week6
BMI:kg/m\*2
Arts' Dumping Questionnaire
时间窗: week 6
Each symptom is scored for severity on a 0-3 Likert scale (0=absent, 1=mild, 2=relevant and 3=severe), the total severity score for dumping syndrome is the sum of severities of all symptoms.
Sigstad's score
时间窗: week6
Sigstad's score: diagnostic index \>7 is suggestive of dumping syndrome. whereas a score \<4 suggests that other diagnoses should be considered.(Shock +5, syncope/unconsciousness +4, Desire to lie or sit down +4, dyspnoea +3, Weakness/exhaustion +3, Sleepiness/drowsiness +3, Palpitation +3, Restlessness +2, Dizziness +2, Headaches +1, Feeling of warmth /sweating +1, Nausea +1, Abdominal fullness +1, Borborygmus +1, Eructation -1, Vomiting -4)
次要结局
- Kidney and Electrolytes-Creatinine(week 6)
- Complete Blood Count (CBC)-MPV(week 6)
- Complete Blood Count (CBC)-MCV(week 6)
- Kidney and Electrolytes-Uric Acid(week 6)
- Complete Blood Count (CBC)-RDW(week 6)
- Kidney and Electrolytes-ACR(week 6)
- Glucose blood levels(week 6)
- Mortality(measured at 3 months, 6 months)
- Kidney and Electrolytes-eGFR(week 6)
- Muscle grip strength test(week6)
- Complete Blood Count (CBC)-WBC(week 6)
- Complete Blood Count (CBC)-RBC(week 6)
- Complete Blood Count (CBC)-Hemoglobin(week 6)
- Complete Blood Count (CBC)-Hematocrit(week 6)
- Complete Blood Count (CBC)-MCH(week 6)
- Complete Blood Count (CBC)-MCHC(week 6)
- Complete Blood Count (CBC)-Platelet(week 6)
- Complete Blood Count (CBC)-PDW(week 6)
- Kidney and Electrolytes-Potassium(week 6)
- Kidney and Electrolytes-Calcium(week 6)
- Erythrocyte Sedimentation Rate (ESR)(week 6)
- Kidney and Electrolytes-Phosphate(week 6)
- Kidney and Electrolytes-Urea(week 6)
- Kidney and Electrolytes-Sodium(week 6)
- Total Intensive care unit (ICU) stay, total hospital stay, total mechanical ventilation in days(measured at 6 months)
- Pre-Albumin(week 6)
- Albumin level(week 6)
- C-reactive Protein (CRP)(week 6)
- Medical charts and drug use.(measured at 3 months, 6 months)
研究者
Peter Karl Mayer
Assistant Professor
China Medical University, Taiwan