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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801666
• Other study ID #: CMU111-S-34
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: China Medical University, Taiwan
• Contact: Peiyu Kao
• Phone: 886-4-22052121
• Email: D20621[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acupuncture
• Dumping Syndrome
• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Other:
• Acupuncture
Acupuncture 5 points

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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