Acupuncture Clinical Trial
Official title:
Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy: A Study Protocol for A Single Blind Randomized Control Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - Advanced esophageal cancer - Post feeding jejunostomy - Plan of CCRT for esophageal cancer Exclusion Criteria: - Acute infection - Unstable vital signs - Other medical conditions which would affect nutrition status |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Weight | Unit: kg | baseline | |
Primary | Body Weight | Unit: kg | week1 | |
Primary | Body Weight | Unit: kg | week2 | |
Primary | Body Weight | Unit: kg | week3 | |
Primary | Body Weight | Unit: kg | week4 | |
Primary | Body Weight | Unit: kg | week5 | |
Primary | Body Weight | Unit: kg | week6 | |
Primary | Body Height | Unit: cm | baseline | |
Primary | Body Height | Unit: cm | week1 | |
Primary | Body Height | Unit: cm | week2 | |
Primary | Body Height | Unit: cm | week3 | |
Primary | Body Height | Unit: cm | week4 | |
Primary | Body Height | Unit: cm | week5 | |
Primary | Body Height | Unit: cm | week6 | |
Primary | Body Mass Index | BMI:kg/m*2 | baseline | |
Primary | Body Mass Index | BMI:kg/m*2 | week1 | |
Primary | Body Mass Index | BMI:kg/m*2 | week2 | |
Primary | Body Mass Index | BMI:kg/m*2 | week3 | |
Primary | Body Mass Index | BMI:kg/m*2 | week4 | |
Primary | Body Mass Index | BMI:kg/m*2 | week5 | |
Primary | Body Mass Index | BMI:kg/m*2 | week6 | |
Primary | Sigstad's score | 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) | baseline | |
Primary | Sigstad's score | 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) | week1 | |
Primary | Sigstad's score | 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) | week2 | |
Primary | Sigstad's score | 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) | week3 | |
Primary | Sigstad's score | 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) | week4 | |
Primary | Sigstad's score | 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) | week5 | |
Primary | Sigstad's score | 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) | week6 | |
Primary | Arts' Dumping Questionnaire | 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. | baseline | |
Primary | Arts' Dumping Questionnaire | 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. | week 1 | |
Primary | Arts' Dumping Questionnaire | 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. | week 2 | |
Primary | Arts' Dumping Questionnaire | 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. | week 3 | |
Primary | Arts' Dumping Questionnaire | 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. | week 4 | |
Primary | Arts' Dumping Questionnaire | 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. | week 5 | |
Primary | Arts' Dumping Questionnaire | 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. | week 6 | |
Secondary | Muscle grip strength test | Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg | baseline | |
Secondary | Muscle grip strength test | Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg | week1 | |
Secondary | Muscle grip strength test | Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg | week2 | |
Secondary | Muscle grip strength test | Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg | week3 | |
Secondary | Muscle grip strength test | Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg | week4 | |
Secondary | Muscle grip strength test | Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg | week5 | |
Secondary | Muscle grip strength test | Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg | week6 | |
Secondary | Complete Blood Count (CBC)-WBC | Unit:1000/µL | baseline | |
Secondary | Complete Blood Count (CBC)-WBC | Unit:1000/µL | week 6 | |
Secondary | Complete Blood Count (CBC)-RBC | Unit:million/µL, | baseline | |
Secondary | Complete Blood Count (CBC)-RBC | Unit:million/µL, | week 6 | |
Secondary | Complete Blood Count (CBC)-Hemoglobin | Unit:g/dL | baseline | |
Secondary | Complete Blood Count (CBC)-Hemoglobin | Unit:g/dL | week 6 | |
Secondary | Complete Blood Count (CBC)-Hematocrit | Unit: % | baseline | |
Secondary | Complete Blood Count (CBC)-Hematocrit | Unit: % | week 6 | |
Secondary | Complete Blood Count (CBC)-MCV | Unit: fL | baseline | |
Secondary | Complete Blood Count (CBC)-MCV | Unit: fL | week 6 | |
Secondary | Complete Blood Count (CBC)-MCH | Unit: pg/cell | baseline | |
Secondary | Complete Blood Count (CBC)-MCH | Unit: pg/cell | week 6 | |
Secondary | Complete Blood Count (CBC)-MCHC | Unit: g/dL | baseline | |
Secondary | Complete Blood Count (CBC)-MCHC | Unit: g/dL | week 6 | |
Secondary | Complete Blood Count (CBC)-RDW | Unit: % | baseline | |
Secondary | Complete Blood Count (CBC)-RDW | Unit: % | week 6 | |
Secondary | Complete Blood Count (CBC)-Platelet | Unit: 1000/µL | baseline | |
Secondary | Complete Blood Count (CBC)-Platelet | Unit: 1000/µL | week 6 | |
Secondary | Complete Blood Count (CBC)-PDW | Unit: fL | baseline | |
Secondary | Complete Blood Count (CBC)-PDW | Unit: fL | week 6 | |
Secondary | Complete Blood Count (CBC)-MPV | Unit: fL | baseline | |
Secondary | Complete Blood Count (CBC)-MPV | Unit: fL | week 6 | |
Secondary | Kidney and Electrolytes-eGFR | Unit: mL/min/1.73m*2 | baseline | |
Secondary | Kidney and Electrolytes-eGFR | Unit: mL/min/1.73m*2 | week 6 | |
Secondary | Kidney and Electrolytes-Creatinine | Unit: mg/dL | baseline | |
Secondary | Kidney and Electrolytes-Creatinine | Unit: mg/dL | week 6 | |
Secondary | Kidney and Electrolytes-ACR | Unit: mg/g | baseline | |
Secondary | Kidney and Electrolytes-ACR | Unit: mg/g | week 6 | |
Secondary | Kidney and Electrolytes-Urea | Unit: g/day | baseline | |
Secondary | Kidney and Electrolytes-Urea | Unit: g/day | week 6 | |
Secondary | Kidney and Electrolytes-Uric Acid | Unit: mg/dL | baseline | |
Secondary | Kidney and Electrolytes-Uric Acid | Unit: mg/dL | week 6 | |
Secondary | Kidney and Electrolytes-Potassium | Unit: mEq/L | baseline | |
Secondary | Kidney and Electrolytes-Potassium | Unit: mEq/L | week 6 | |
Secondary | Kidney and Electrolytes-Sodium | Unit: mEq/L | baseline | |
Secondary | Kidney and Electrolytes-Sodium | Unit: mEq/L | week 6 | |
Secondary | Kidney and Electrolytes-Calcium | Unit: mg/dL | baseline | |
Secondary | Kidney and Electrolytes-Calcium | Unit: mg/dL | week 6 | |
Secondary | Kidney and Electrolytes-Phosphate | Unit: mg/dL | baseline | |
Secondary | Kidney and Electrolytes-Phosphate | Unit: mg/dL | week 6 | |
Secondary | Pre-Albumin | Unit: mg/dL | baseline | |
Secondary | Pre-Albumin | Unit: mg/dL | week 6 | |
Secondary | Albumin level | Unit: g/dL | baseline | |
Secondary | Albumin level | Unit: g/dL | week 6 | |
Secondary | Glucose blood levels | Unit: mg/dL | baseline | |
Secondary | Glucose blood levels | Unit: mg/dL | week 6 | |
Secondary | Erythrocyte Sedimentation Rate (ESR) | Unit: mm/h | baseline | |
Secondary | Erythrocyte Sedimentation Rate (ESR) | Unit: mm/h | week 6 | |
Secondary | C-reactive Protein (CRP) | Unit: mg/L | baseline | |
Secondary | C-reactive Protein (CRP) | Unit: mg/L | week 6 | |
Secondary | Total Intensive care unit (ICU) stay, total hospital stay, total mechanical ventilation in days | Hospital satistics | measured at 6 months | |
Secondary | Mortality | Hospital statistics | measured at 3 months, 6 months | |
Secondary | Medical charts and drug use. | Hospital statistics | measured at 3 months, 6 months |
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