Esophagus CancerNCT05801666
Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy
A study testing Acupuncture in people with Esophagus Cancer and Acupuncture, run by China Medical University, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophagus Cancer, Acupuncture
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced esophageal cancer
- Post feeding jejunostomy
- Plan of CCRT for esophageal cancer
Who cannot join
- Acute infection
- Unstable vital signs
- Other medical conditions which would affect nutrition status
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Peiyu Kao, 886-4-22052121, D20621@mail.cmuh.org.tw
Peter Mayer, 86-4-22053366 ext. 3007, piotrmayer@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Esophagus Cancer, Acupuncture
- Being tested
- Acupuncture
- Keywords
- Esophagus Cancer, Acupuncture
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture 5 points
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Acupuncture points: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) Liv 3(Taichung). Receives: Other: Acupuncture |
| Control group | Sham comparator | 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Unit: kg
Measured: baseline
Body Weight
Unit: kg
Measured: week1
Body Weight
Unit: kg
Measured: week2
Body Weight
Unit: kg
Measured: week3
Body Weight
Unit: kg
Measured: week4
Body Weight
Unit: kg
Measured: week5
Body Weight
Unit: kg
Measured: week6
Body Height
Unit: cm
Measured: baseline
Body Height
Unit: cm
Measured: week1
Body Height
Unit: cm
Measured: week2
Body Height
Unit: cm
Measured: week3
Body Height
Unit: cm
Measured: week4
Body Height
Unit: cm
Measured: week5
Body Height
Unit: cm
Measured: week6
Body Mass Index
BMI:kg/m*2
Measured: baseline
Body Mass Index
BMI:kg/m*2
Measured: week1
Body Mass Index
BMI:kg/m*2
Measured: week2
Body Mass Index
BMI:kg/m*2
Measured: week3
Body Mass Index
BMI:kg/m*2
Measured: week4
Body Mass Index
BMI:kg/m*2
Measured: week5
Body Mass Index
BMI:kg/m*2
Measured: week6
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)
Measured: baseline
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)
Measured: week1
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)
Measured: week2
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)
Measured: week3
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)
Measured: week4
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)
Measured: week5
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)
Measured: week6
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.
Measured: baseline
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.
Measured: week 1
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.
Measured: week 2
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.
Measured: week 3
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.
Measured: week 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.
Measured: week 5
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.
Measured: week 6
Secondary outcomes (60)
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Measured: baseline
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Measured: week1
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Measured: week2
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Measured: week3
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Measured: week4
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Measured: week5
Muscle grip strength test
Electronic Hand Dyanmometer(EH101)), Unit: kg, Max Capacity: 90kg
Measured: week6
Complete Blood Count (CBC)-WBC
Unit:1000/μL
Measured: baseline
Complete Blood Count (CBC)-WBC
Unit:1000/μL
Measured: week 6
Complete Blood Count (CBC)-RBC
Unit:million/μL,
Measured: baseline
Complete Blood Count (CBC)-RBC
Unit:million/μL,
Measured: week 6
Complete Blood Count (CBC)-Hemoglobin
Unit:g/dL
Measured: baseline
Complete Blood Count (CBC)-Hemoglobin
Unit:g/dL
Measured: week 6
Complete Blood Count (CBC)-Hematocrit
Unit: %
Measured: baseline
Complete Blood Count (CBC)-Hematocrit
Unit: %
Measured: week 6
Complete Blood Count (CBC)-MCV
Unit: fL
Measured: baseline
Complete Blood Count (CBC)-MCV
Unit: fL
Measured: week 6
Complete Blood Count (CBC)-MCH
Unit: pg/cell
Measured: baseline
Complete Blood Count (CBC)-MCH
Unit: pg/cell
Measured: week 6
Complete Blood Count (CBC)-MCHC
Unit: g/dL
Measured: baseline
Complete Blood Count (CBC)-MCHC
Unit: g/dL
Measured: week 6
Complete Blood Count (CBC)-RDW
Unit: %
Measured: baseline
Complete Blood Count (CBC)-RDW
Unit: %
Measured: week 6
Complete Blood Count (CBC)-Platelet
Unit: 1000/μL
Measured: baseline
Complete Blood Count (CBC)-Platelet
Unit: 1000/μL
Measured: week 6
Complete Blood Count (CBC)-PDW
Unit: fL
Measured: baseline
Complete Blood Count (CBC)-PDW
Unit: fL
Measured: week 6
Complete Blood Count (CBC)-MPV
Unit: fL
Measured: baseline
Complete Blood Count (CBC)-MPV
Unit: fL
Measured: week 6
Kidney and Electrolytes-eGFR
Unit: mL/min/1.73m*2
Measured: baseline
Kidney and Electrolytes-eGFR
Unit: mL/min/1.73m*2
Measured: week 6
Kidney and Electrolytes-Creatinine
Unit: mg/dL
Measured: baseline
Kidney and Electrolytes-Creatinine
Unit: mg/dL
Measured: week 6
Kidney and Electrolytes-ACR
Unit: mg/g
Measured: baseline
Kidney and Electrolytes-ACR
Unit: mg/g
Measured: week 6
Kidney and Electrolytes-Urea
Unit: g/day
Measured: baseline
Kidney and Electrolytes-Urea
Unit: g/day
Measured: week 6
Kidney and Electrolytes-Uric Acid
Unit: mg/dL
Measured: baseline
Kidney and Electrolytes-Uric Acid
Unit: mg/dL
Measured: week 6
Kidney and Electrolytes-Potassium
Unit: mEq/L
Measured: baseline
Kidney and Electrolytes-Potassium
Unit: mEq/L
Measured: week 6
Kidney and Electrolytes-Sodium
Unit: mEq/L
Measured: baseline
Kidney and Electrolytes-Sodium
Unit: mEq/L
Measured: week 6
Kidney and Electrolytes-Calcium
Unit: mg/dL
Measured: baseline
Kidney and Electrolytes-Calcium
Unit: mg/dL
Measured: week 6
Kidney and Electrolytes-Phosphate
Unit: mg/dL
Measured: baseline
Kidney and Electrolytes-Phosphate
Unit: mg/dL
Measured: week 6
Pre-Albumin
Unit: mg/dL
Measured: baseline
Pre-Albumin
Unit: mg/dL
Measured: week 6
Albumin level
Unit: g/dL
Measured: baseline
Albumin level
Unit: g/dL
Measured: week 6
Glucose blood levels
Unit: mg/dL
Measured: baseline
Glucose blood levels
Unit: mg/dL
Measured: week 6
Erythrocyte Sedimentation Rate (ESR)
Unit: mm/h
Measured: baseline
Erythrocyte Sedimentation Rate (ESR)
Unit: mm/h
Measured: week 6
C-reactive Protein (CRP)
Unit: mg/L
Measured: baseline
C-reactive Protein (CRP)
Unit: mg/L
Measured: week 6
Total Intensive care unit (ICU) stay, total hospital stay, total mechanical ventilation in days
Hospital satistics
Measured: measured at 6 months
Mortality
Hospital statistics
Measured: measured at 3 months, 6 months
Medical charts and drug use.
Hospital statistics
Measured: measured at 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start10 Feb 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Karl Mayer, China Medical University, Taiwan
- Investigators
- Peter Mayer, Study director, China Medical University,Taichung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801666
- Sponsor's protocol ID
- CMU111-S-34
- Status last verified
- May 2023
- First submitted
- 14 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mayer PK, Kao PY, Lee YC, Liao YF, Ho WC, Ben-Arie E. Acupuncture effect on dumping syndrome in esophagus cancer patients with feeding jejunostomy: A study protocol for a single blind randomized control trial. Medicine (Baltimore). 2023 Jun 9;102(23):e33895. doi: 10.1097/MD.0000000000033895.
PubMed 37335662
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Effect on Dumping Syndrome in Esophagus Cancer Patients With Feeding Jejunostomy: A Study Protocol for A Single Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05801666
- Acronym / sponsor ID
- CMU111-S-34
- Conditions
- Esophagus Cancer, Acupuncture
- Keywords
- Esophagus Cancer, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University, TaiwanUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: AcupunctureAcupuncture points: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), and LI4 (Hegu) Liv 3(Taichung). |
| Control group | Sham comparator | Other: AcupunctureAcupuncture 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced esophageal cancer
- Post feeding jejunostomy
- Plan of CCRT for esophageal cancer
Key exclusion criteria (3 listed)
- Acute infection
- Unstable vital signs
- Other medical conditions which would affect nutrition status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 5 points | Other | Acupuncture group, Control group |
Primary outcome
Body Weight
Time frame: baseline
Unit: kg
Body Weight
Time frame: week1
Unit: kg
Body Weight
Time frame: week2
Unit: kg
Body Weight
Time frame: week3
Unit: kg
Body Weight
Time frame: week4
Unit: kg
Body Weight
Time frame: week5
Unit: kg
Body Weight
Time frame: week6
Unit: kg
Body Height
Time frame: baseline
Unit: cm
Body Height
Time frame: week1
Unit: cm
Body Height
Time frame: week2
Unit: cm
Body Height
Time frame: week3
Unit: cm
Body Height
Time frame: week4
Unit: cm
Body Height
Time frame: week5
Unit: cm
Body Height
Time frame: week6
Unit: cm
Body Mass Index
Time frame: baseline
BMI:kg/m*2
Body Mass Index
Time frame: week1
BMI:kg/m*2
Body Mass Index
Time frame: week2
BMI:kg/m*2
Body Mass Index
Time frame: week3
BMI:kg/m*2
Body Mass Index
Time frame: week4
BMI:kg/m*2
Body Mass Index
Time frame: week5
BMI:kg/m*2
Body Mass Index
Time frame: week6
BMI:kg/m*2
Sigstad's score
Time frame: baseline
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
Time frame: week1
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
Time frame: week2
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
Time frame: week3
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
Time frame: week4
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
Time frame: week5
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
Time frame: 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)
Arts' Dumping Questionnaire
Time frame: baseline
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
Time frame: week 1
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
Time frame: week 2
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
Time frame: week 3
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
Time frame: week 4
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
Time frame: week 5
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
Time frame: 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.
60 secondary outcomes
Muscle grip strength test
Time frame: baseline
Muscle grip strength test
Time frame: week1
Muscle grip strength test
Time frame: week2
Muscle grip strength test
Time frame: week3
Muscle grip strength test
Time frame: week4
Muscle grip strength test
Time frame: week5
Muscle grip strength test
Time frame: week6
Complete Blood Count (CBC)-WBC
Time frame: baseline
Complete Blood Count (CBC)-WBC
Time frame: week 6
Complete Blood Count (CBC)-RBC
Time frame: baseline
Complete Blood Count (CBC)-RBC
Time frame: week 6
Complete Blood Count (CBC)-Hemoglobin
Time frame: baseline
Complete Blood Count (CBC)-Hemoglobin
Time frame: week 6
Complete Blood Count (CBC)-Hematocrit
Time frame: baseline
Complete Blood Count (CBC)-Hematocrit
Time frame: week 6
Complete Blood Count (CBC)-MCV
Time frame: baseline
Complete Blood Count (CBC)-MCV
Time frame: week 6
Complete Blood Count (CBC)-MCH
Time frame: baseline
Complete Blood Count (CBC)-MCH
Time frame: week 6
Complete Blood Count (CBC)-MCHC
Time frame: baseline
Complete Blood Count (CBC)-MCHC
Time frame: week 6
Complete Blood Count (CBC)-RDW
Time frame: baseline
Complete Blood Count (CBC)-RDW
Time frame: week 6
Complete Blood Count (CBC)-Platelet
Time frame: baseline
Complete Blood Count (CBC)-Platelet
Time frame: week 6
Complete Blood Count (CBC)-PDW
Time frame: baseline
Complete Blood Count (CBC)-PDW
Time frame: week 6
Complete Blood Count (CBC)-MPV
Time frame: baseline
Complete Blood Count (CBC)-MPV
Time frame: week 6
Kidney and Electrolytes-eGFR
Time frame: baseline
Kidney and Electrolytes-eGFR
Time frame: week 6
Kidney and Electrolytes-Creatinine
Time frame: baseline
Kidney and Electrolytes-Creatinine
Time frame: week 6
Kidney and Electrolytes-ACR
Time frame: baseline
Kidney and Electrolytes-ACR
Time frame: week 6
Kidney and Electrolytes-Urea
Time frame: baseline
Kidney and Electrolytes-Urea
Time frame: week 6
Kidney and Electrolytes-Uric Acid
Time frame: baseline
Kidney and Electrolytes-Uric Acid
Time frame: week 6
Kidney and Electrolytes-Potassium
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 37335662Mayer PK, Kao PY, Lee YC, Liao YF, Ho WC, Ben-Arie E. Acupuncture effect on dumping syndrome in esophagus cancer patients with feeding jejunostomy: A study protocol for a single blind randomized control trial. Medicine (Baltimore). 2023 Jun 9;102(23):e33895. doi: 10.1097/MD.0000000000033895.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Mayer study director
China Medical University,Taichung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Esophagus Cancer and Acupuncture, run by China Medical University, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peiyu Kao (886-4-22052121, D20621@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: baseline). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.