Clinical trial NCT05801666: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagus Cancer
Acupuncture
Keywords: Esophagus Cancer
Acupuncture
Lead sponsor: China Medical University, Taiwan
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Body Weight
timeFrame: baseline
measure: Body Weight
timeFrame: week1
measure: Body Weight
timeFrame: week2
measure: Body Weight
timeFrame: week3
measure: Body Weight
timeFrame: week4
measure: Body Weight
timeFrame: week5
measure: Body Weight
timeFrame: week6
measure: Body Height
timeFrame: baseline
measure: Body Height
timeFrame: week1
measure: Body Height
timeFrame: week2
measure: Body Height
timeFrame: week3
measure: Body Height
timeFrame: week4
measure: Body Height
timeFrame: week5
measure: Body Height
timeFrame: week6
measure: Body Mass Index
timeFrame: baseline
measure: Body Mass Index
timeFrame: week1
measure: Body Mass Index
timeFrame: week2
measure: Body Mass Index
timeFrame: week3
measure: Body Mass Index
timeFrame: week4
measure: Body Mass Index
timeFrame: week5
measure: Body Mass Index
timeFrame: week6
measure: Sigstad's score
timeFrame: baseline
measure: Sigstad's score
timeFrame: week1
measure: Sigstad's score
timeFrame: week2
measure: Sigstad's score
timeFrame: week3
measure: Sigstad's score
timeFrame: week4
measure: Sigstad's score
timeFrame: week5
measure: Sigstad's score
timeFrame: week6
measure: Arts' Dumping Questionnaire
timeFrame: baseline
measure: Arts' Dumping Questionnaire
timeFrame: week 1
measure: Arts' Dumping Questionnaire
timeFrame: week 2
measure: Arts' Dumping Questionnaire
timeFrame: week 3
measure: Arts' Dumping Questionnaire
timeFrame: week 4
measure: Arts' Dumping Questionnaire
timeFrame: week 5
measure: Arts' Dumping Questionnaire
timeFrame: week 6
Secondary outcomes:
measure: Muscle grip strength test
timeFrame: baseline
measure: Muscle grip strength test
timeFrame: week1
measure: Muscle grip strength test
timeFrame: week2
measure: Muscle grip strength test
timeFrame: week3
measure: Muscle grip strength test
timeFrame: week4
measure: Muscle grip strength test
timeFrame: week5
measure: Muscle grip strength test
timeFrame: week6
measure: Complete Blood Count (CBC)-WBC
timeFrame: baseline
measure: Complete Blood Count (CBC)-WBC
timeFrame: week 6
measure: Complete Blood Count (CBC)-RBC
timeFrame: baseline
measure: Complete Blood Count (CBC)-RBC
timeFrame: week 6
measure: Complete Blood Count (CBC)-Hemoglobin
timeFrame: baseline
measure: Complete Blood Count (CBC)-Hemoglobin
timeFrame: week 6
measure: Complete Blood Count (CBC)-Hematocrit
timeFrame: baseline
measure: Complete Blood Count (CBC)-Hematocrit
timeFrame: week 6
measure: Complete Blood Count (CBC)-MCV
timeFrame: baseline
measure: Complete Blood Count (CBC)-MCV
timeFrame: week 6
measure: Complete Blood Count (CBC)-MCH
timeFrame: baseline
measure: Complete Blood Count (CBC)-MCH
timeFrame: week 6
measure: Complete Blood Count (CBC)-MCHC
timeFrame: baseline
measure: Complete Blood Count (CBC)-MCHC
timeFrame: week 6
measure: Complete Blood Count (CBC)-RDW
timeFrame: baseline
measure: Complete Blood Count (CBC)-RDW
timeFrame: week 6
measure: Complete Blood Count (CBC)-Platelet
timeFrame: baseline
measure: Complete Blood Count (CBC)-Platelet
timeFrame: week 6
measure: Complete Blood Count (CBC)-PDW
timeFrame: baseline
measure: Complete Blood Count (CBC)-PDW
timeFrame: week 6
measure: Complete Blood Count (CBC)-MPV
timeFrame: baseline
measure: Complete Blood Count (CBC)-MPV
timeFrame: week 6
measure: Kidney and Electrolytes-eGFR
timeFrame: baseline
measure: Kidney and Electrolytes-eGFR
timeFrame: week 6
measure: Kidney and Electrolytes-Creatinine
timeFrame: baseline
measure: Kidney and Electrolytes-Creatinine
timeFrame: week 6
measure: Kidney and Electrolytes-ACR
timeFrame: baseline
measure: Kidney and Electrolytes-ACR
timeFrame: week 6
measure: Kidney and Electrolytes-Urea
timeFrame: baseline
measure: Kidney and Electrolytes-Urea
timeFrame: week 6
measure: Kidney and Electrolytes-Uric Acid
timeFrame: baseline
measure: Kidney and Electrolytes-Uric Acid
timeFrame: week 6
measure: Kidney and Electrolytes-Potassium
timeFrame: baseline
measure: Kidney and Electrolytes-Potassium
timeFrame: week 6
measure: Kidney and Electrolytes-Sodium
timeFrame: baseline
measure: Kidney and Electrolytes-Sodium
timeFrame: week 6
measure: Kidney and Electrolytes-Calcium
timeFrame: baseline
measure: Kidney and Electrolytes-Calcium
timeFrame: week 6
measure: Kidney and Electrolytes-Phosphate
timeFrame: baseline
measure: Kidney and Electrolytes-Phosphate
timeFrame: week 6
measure: Pre-Albumin
timeFrame: baseline
measure: Pre-Albumin
timeFrame: week 6
measure: Albumin level
timeFrame: baseline
measure: Albumin level
timeFrame: week 6
measure: Glucose blood levels
timeFrame: baseline
measure: Glucose blood levels
timeFrame: week 6
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: baseline
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: week 6
measure: C-reactive Protein (CRP)
timeFrame: baseline
measure: C-reactive Protein (CRP)
timeFrame: week 6
measure: Total Intensive care unit (ICU) stay, total hospital stay, total mechanical ventilation in days
timeFrame: measured at 6 months
measure: Mortality
timeFrame: measured at 3 months, 6 months
measure: Medical charts and drug use.
timeFrame: measured at 3 months, 6 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University,Taichung, Taiwan
name: Peter Mayer
role: STUDY_DIRECTOR
References: