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Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy

Primary Purpose

Esophagus Cancer, Acupuncture

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
China Medical University, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Esophagus Cancer focused on measuring Esophagus Cancer, Acupuncture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture group

Control group

Arm Description

Acupuncture points: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) Liv 3(Taichung).

Acupuncture on the sham points: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) Liv 3(Taichung)(Sham 1~5). Those points are not indicated to treat digestion in Chinese medicine and in a location of 1 cm lateral/medial and 1 cm distal/proximal to those points there is no acupuncture point.

Outcomes

Primary Outcome Measures

Body Weight
Unit: kg
Body Weight
Unit: kg
Body Weight
Unit: kg
Body Weight
Unit: kg
Body Weight
Unit: kg
Body Weight
Unit: kg
Body Weight
Unit: kg
Body Height
Unit: cm
Body Height
Unit: cm
Body Height
Unit: cm
Body Height
Unit: cm
Body Height
Unit: cm
Body Height
Unit: cm
Body Height
Unit: cm
Body Mass Index
BMI:kg/m*2
Body Mass Index
BMI:kg/m*2
Body Mass Index
BMI:kg/m*2
Body Mass Index
BMI:kg/m*2
Body Mass Index
BMI:kg/m*2
Body Mass Index
BMI:kg/m*2
Body Mass Index
BMI:kg/m*2
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)
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)
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Complete Blood Count (CBC)-WBC
Unit:1000/μL
Complete Blood Count (CBC)-WBC
Unit:1000/μL
Complete Blood Count (CBC)-RBC
Unit:million/μL,
Complete Blood Count (CBC)-RBC
Unit:million/μL,
Complete Blood Count (CBC)-Hemoglobin
Unit:g/dL
Complete Blood Count (CBC)-Hemoglobin
Unit:g/dL
Complete Blood Count (CBC)-Hematocrit
Unit: %
Complete Blood Count (CBC)-Hematocrit
Unit: %
Complete Blood Count (CBC)-MCV
Unit: fL
Complete Blood Count (CBC)-MCV
Unit: fL
Complete Blood Count (CBC)-MCH
Unit: pg/cell
Complete Blood Count (CBC)-MCH
Unit: pg/cell
Complete Blood Count (CBC)-MCHC
Unit: g/dL
Complete Blood Count (CBC)-MCHC
Unit: g/dL
Complete Blood Count (CBC)-RDW
Unit: %
Complete Blood Count (CBC)-RDW
Unit: %
Complete Blood Count (CBC)-Platelet
Unit: 1000/μL
Complete Blood Count (CBC)-Platelet
Unit: 1000/μL
Complete Blood Count (CBC)-PDW
Unit: fL
Complete Blood Count (CBC)-PDW
Unit: fL
Complete Blood Count (CBC)-MPV
Unit: fL
Complete Blood Count (CBC)-MPV
Unit: fL
Kidney and Electrolytes-eGFR
Unit: mL/min/1.73m*2
Kidney and Electrolytes-eGFR
Unit: mL/min/1.73m*2
Kidney and Electrolytes-Creatinine
Unit: mg/dL
Kidney and Electrolytes-Creatinine
Unit: mg/dL
Kidney and Electrolytes-ACR
Unit: mg/g
Kidney and Electrolytes-ACR
Unit: mg/g
Kidney and Electrolytes-Urea
Unit: g/day
Kidney and Electrolytes-Urea
Unit: g/day
Kidney and Electrolytes-Uric Acid
Unit: mg/dL
Kidney and Electrolytes-Uric Acid
Unit: mg/dL
Kidney and Electrolytes-Potassium
Unit: mEq/L
Kidney and Electrolytes-Potassium
Unit: mEq/L
Kidney and Electrolytes-Sodium
Unit: mEq/L
Kidney and Electrolytes-Sodium
Unit: mEq/L
Kidney and Electrolytes-Calcium
Unit: mg/dL
Kidney and Electrolytes-Calcium
Unit: mg/dL
Kidney and Electrolytes-Phosphate
Unit: mg/dL
Kidney and Electrolytes-Phosphate
Unit: mg/dL
Pre-Albumin
Unit: mg/dL
Pre-Albumin
Unit: mg/dL
Albumin level
Unit: g/dL
Albumin level
Unit: g/dL
Glucose blood levels
Unit: mg/dL
Glucose blood levels
Unit: mg/dL
Erythrocyte Sedimentation Rate (ESR)
Unit: mm/h
Erythrocyte Sedimentation Rate (ESR)
Unit: mm/h
C-reactive Protein (CRP)
Unit: mg/L
C-reactive Protein (CRP)
Unit: mg/L
Total Intensive care unit (ICU) stay, total hospital stay, total mechanical ventilation in days
Hospital satistics
Mortality
Hospital statistics
Medical charts and drug use.
Hospital statistics

Full Information

First Posted
February 14, 2023
Last Updated
May 3, 2023
Sponsor
China Medical University, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05801666
Brief Title
Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy
Official Title
Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy: A Study Protocol for A Single Blind Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. In addition to routine western medicine treatments, patients in the intervention group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) liv 3(Taichung). The acupoints indications in this group are specific to treat indigestion-related conditions. The effectiveness of those points in treating digestion (with exception of liv 3(Taichung)) was shown in our previous research. The treatment will take place once a day, for 2 times a week for 6 weeks. A total of 12 needles will be used in each session. Acupuncture treatment will be performed with sterile needles manufactured by "Yu Kuang" acupuncture needles 40mm with 30G. The patients in the control group will receive a bilateral shallow acupuncture (12 needles) on the sham points that are located 1 cm lateral/medial and 1 cm distal/proximal to the following acupoints: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) liv 3 (Taichung) (figure 3). Those points are not indicated to treat digestion in Chinese medicine and in a location of 1 cm lateral/medial and 1 cm distal/proximal to those points there is no acupuncture point. The needle insertion will be a perpendicular shallow insertion into the skin tissue level. The acupuncture doctor will use the needle with tube insertion for needle insertion and will leave the needle in the depth of the tube insertion (approximately 4 mm depth into the skin) without needle manipulation. Needle retention time will be 30 minutes. In addition to the sham points, the patients in this group will also receive routine western medicine treatment as per each patient's needs. The treatment frequency and skin disinfection will be identical to the treatment group. Main outcome measurements are: body weight, Body Mass Index (BMI) (will be measured weekly) dumping syndrome questioners: the Sigstad's score and the Arts' dumping questionnaire (will be measured on the baseline, week3, week 6). The secondary outcomes are: muscle grip strength test (measured weekly) blood test: Complete Blood Count (CBC), kidney and electrolytes (measured as Adjuvant Concurrent Chemoradiation Therapy (CCRT) schedule), pre-albumin, albumin level, glucose blood levels, inflammation data including Erythrocyte Sedimentation Rate (ESR) and C-reactive Protein (CRP) (measured at baseline and on week 6). Total Intensive care unit (ICU) stay, total hospital stay, total mechanical ventilation in days, will be measured 6 months after inclusion. Mortality will be measured at 3 months, 6 months. Medical charts and drug use will also be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Acupuncture
Keywords
Esophagus Cancer, Acupuncture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
Acupuncture points: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) Liv 3(Taichung).
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Acupuncture on the sham points: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) Liv 3(Taichung)(Sham 1~5). Those points are not indicated to treat digestion in Chinese medicine and in a location of 1 cm lateral/medial and 1 cm distal/proximal to those points there is no acupuncture point.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture 5 points
Primary Outcome Measure Information:
Title
Body Weight
Description
Unit: kg
Time Frame
baseline
Title
Body Weight
Description
Unit: kg
Time Frame
week1
Title
Body Weight
Description
Unit: kg
Time Frame
week2
Title
Body Weight
Description
Unit: kg
Time Frame
week3
Title
Body Weight
Description
Unit: kg
Time Frame
week4
Title
Body Weight
Description
Unit: kg
Time Frame
week5
Title
Body Weight
Description
Unit: kg
Time Frame
week6
Title
Body Height
Description
Unit: cm
Time Frame
baseline
Title
Body Height
Description
Unit: cm
Time Frame
week1
Title
Body Height
Description
Unit: cm
Time Frame
week2
Title
Body Height
Description
Unit: cm
Time Frame
week3
Title
Body Height
Description
Unit: cm
Time Frame
week4
Title
Body Height
Description
Unit: cm
Time Frame
week5
Title
Body Height
Description
Unit: cm
Time Frame
week6
Title
Body Mass Index
Description
BMI:kg/m*2
Time Frame
baseline
Title
Body Mass Index
Description
BMI:kg/m*2
Time Frame
week1
Title
Body Mass Index
Description
BMI:kg/m*2
Time Frame
week2
Title
Body Mass Index
Description
BMI:kg/m*2
Time Frame
week3
Title
Body Mass Index
Description
BMI:kg/m*2
Time Frame
week4
Title
Body Mass Index
Description
BMI:kg/m*2
Time Frame
week5
Title
Body Mass Index
Description
BMI:kg/m*2
Time Frame
week6
Title
Sigstad's score
Description
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)
Time Frame
baseline
Title
Sigstad's score
Description
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)
Time Frame
week1
Title
Sigstad's score
Description
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)
Time Frame
week2
Title
Sigstad's score
Description
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)
Time Frame
week3
Title
Sigstad's score
Description
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)
Time Frame
week4
Title
Sigstad's score
Description
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)
Time Frame
week5
Title
Sigstad's score
Description
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)
Time Frame
week6
Title
Arts' Dumping Questionnaire
Description
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.
Time Frame
baseline
Title
Arts' Dumping Questionnaire
Description
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.
Time Frame
week 1
Title
Arts' Dumping Questionnaire
Description
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.
Time Frame
week 2
Title
Arts' Dumping Questionnaire
Description
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.
Time Frame
week 3
Title
Arts' Dumping Questionnaire
Description
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.
Time Frame
week 4
Title
Arts' Dumping Questionnaire
Description
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.
Time Frame
week 5
Title
Arts' Dumping Questionnaire
Description
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.
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Muscle grip strength test
Description
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Time Frame
baseline
Title
Muscle grip strength test
Description
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Time Frame
week1
Title
Muscle grip strength test
Description
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Time Frame
week2
Title
Muscle grip strength test
Description
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Time Frame
week3
Title
Muscle grip strength test
Description
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Time Frame
week4
Title
Muscle grip strength test
Description
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Time Frame
week5
Title
Muscle grip strength test
Description
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Time Frame
week6
Title
Complete Blood Count (CBC)-WBC
Description
Unit:1000/μL
Time Frame
baseline
Title
Complete Blood Count (CBC)-WBC
Description
Unit:1000/μL
Time Frame
week 6
Title
Complete Blood Count (CBC)-RBC
Description
Unit:million/μL,
Time Frame
baseline
Title
Complete Blood Count (CBC)-RBC
Description
Unit:million/μL,
Time Frame
week 6
Title
Complete Blood Count (CBC)-Hemoglobin
Description
Unit:g/dL
Time Frame
baseline
Title
Complete Blood Count (CBC)-Hemoglobin
Description
Unit:g/dL
Time Frame
week 6
Title
Complete Blood Count (CBC)-Hematocrit
Description
Unit: %
Time Frame
baseline
Title
Complete Blood Count (CBC)-Hematocrit
Description
Unit: %
Time Frame
week 6
Title
Complete Blood Count (CBC)-MCV
Description
Unit: fL
Time Frame
baseline
Title
Complete Blood Count (CBC)-MCV
Description
Unit: fL
Time Frame
week 6
Title
Complete Blood Count (CBC)-MCH
Description
Unit: pg/cell
Time Frame
baseline
Title
Complete Blood Count (CBC)-MCH
Description
Unit: pg/cell
Time Frame
week 6
Title
Complete Blood Count (CBC)-MCHC
Description
Unit: g/dL
Time Frame
baseline
Title
Complete Blood Count (CBC)-MCHC
Description
Unit: g/dL
Time Frame
week 6
Title
Complete Blood Count (CBC)-RDW
Description
Unit: %
Time Frame
baseline
Title
Complete Blood Count (CBC)-RDW
Description
Unit: %
Time Frame
week 6
Title
Complete Blood Count (CBC)-Platelet
Description
Unit: 1000/μL
Time Frame
baseline
Title
Complete Blood Count (CBC)-Platelet
Description
Unit: 1000/μL
Time Frame
week 6
Title
Complete Blood Count (CBC)-PDW
Description
Unit: fL
Time Frame
baseline
Title
Complete Blood Count (CBC)-PDW
Description
Unit: fL
Time Frame
week 6
Title
Complete Blood Count (CBC)-MPV
Description
Unit: fL
Time Frame
baseline
Title
Complete Blood Count (CBC)-MPV
Description
Unit: fL
Time Frame
week 6
Title
Kidney and Electrolytes-eGFR
Description
Unit: mL/min/1.73m*2
Time Frame
baseline
Title
Kidney and Electrolytes-eGFR
Description
Unit: mL/min/1.73m*2
Time Frame
week 6
Title
Kidney and Electrolytes-Creatinine
Description
Unit: mg/dL
Time Frame
baseline
Title
Kidney and Electrolytes-Creatinine
Description
Unit: mg/dL
Time Frame
week 6
Title
Kidney and Electrolytes-ACR
Description
Unit: mg/g
Time Frame
baseline
Title
Kidney and Electrolytes-ACR
Description
Unit: mg/g
Time Frame
week 6
Title
Kidney and Electrolytes-Urea
Description
Unit: g/day
Time Frame
baseline
Title
Kidney and Electrolytes-Urea
Description
Unit: g/day
Time Frame
week 6
Title
Kidney and Electrolytes-Uric Acid
Description
Unit: mg/dL
Time Frame
baseline
Title
Kidney and Electrolytes-Uric Acid
Description
Unit: mg/dL
Time Frame
week 6
Title
Kidney and Electrolytes-Potassium
Description
Unit: mEq/L
Time Frame
baseline
Title
Kidney and Electrolytes-Potassium
Description
Unit: mEq/L
Time Frame
week 6
Title
Kidney and Electrolytes-Sodium
Description
Unit: mEq/L
Time Frame
baseline
Title
Kidney and Electrolytes-Sodium
Description
Unit: mEq/L
Time Frame
week 6
Title
Kidney and Electrolytes-Calcium
Description
Unit: mg/dL
Time Frame
baseline
Title
Kidney and Electrolytes-Calcium
Description
Unit: mg/dL
Time Frame
week 6
Title
Kidney and Electrolytes-Phosphate
Description
Unit: mg/dL
Time Frame
baseline
Title
Kidney and Electrolytes-Phosphate
Description
Unit: mg/dL
Time Frame
week 6
Title
Pre-Albumin
Description
Unit: mg/dL
Time Frame
baseline
Title
Pre-Albumin
Description
Unit: mg/dL
Time Frame
week 6
Title
Albumin level
Description
Unit: g/dL
Time Frame
baseline
Title
Albumin level
Description
Unit: g/dL
Time Frame
week 6
Title
Glucose blood levels
Description
Unit: mg/dL
Time Frame
baseline
Title
Glucose blood levels
Description
Unit: mg/dL
Time Frame
week 6
Title
Erythrocyte Sedimentation Rate (ESR)
Description
Unit: mm/h
Time Frame
baseline
Title
Erythrocyte Sedimentation Rate (ESR)
Description
Unit: mm/h
Time Frame
week 6
Title
C-reactive Protein (CRP)
Description
Unit: mg/L
Time Frame
baseline
Title
C-reactive Protein (CRP)
Description
Unit: mg/L
Time Frame
week 6
Title
Total Intensive care unit (ICU) stay, total hospital stay, total mechanical ventilation in days
Description
Hospital satistics
Time Frame
measured at 6 months
Title
Mortality
Description
Hospital statistics
Time Frame
measured at 3 months, 6 months
Title
Medical charts and drug use.
Description
Hospital statistics
Time Frame
measured at 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peiyu Kao
Phone
886-4-22052121
Email
D20621@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mayer
Organizational Affiliation
China Medical University,Taichung, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiyu Kao
Phone
886-4-22052121
Email
D20621@mail.cmuh.org.tw
First Name & Middle Initial & Last Name & Degree
Peter Mayer
Phone
86-4-22053366
Ext
3007
Email
piotrmayer@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy

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