NCT05801666

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

February 14, 2023

Last Update Submit

May 3, 2023

Conditions

Esophagus CancerAcupuncture

Keywords

Esophagus CancerAcupuncture

Outcome Measures

Primary Outcomes (35)

  • Body Weight

    Unit: kg

    baseline

  • Body Weight

    Unit: kg

    week1

  • Body Weight

    Unit: kg

    week2

  • Body Weight

    Unit: kg

    week3

  • Body Weight

    Unit: kg

    week4

  • Body Weight

    Unit: kg

    week5

  • Body Weight

    Unit: kg

    week6

  • Body Height

    Unit: cm

    baseline

  • Body Height

    Unit: cm

    week1

  • Body Height

    Unit: cm

    week2

  • Body Height

    Unit: cm

    week3

  • Body Height

    Unit: cm

    week4

  • Body Height

    Unit: cm

    week5

  • Body Height

    Unit: cm

    week6

  • Body Mass Index

    BMI:kg/m\*2

    baseline

  • Body Mass Index

    BMI:kg/m\*2

    week1

  • Body Mass Index

    BMI:kg/m\*2

    week2

  • Body Mass Index

    BMI:kg/m\*2

    week3

  • Body Mass Index

    BMI:kg/m\*2

    week4

  • Body Mass Index

    BMI:kg/m\*2

    week5

  • Body Mass Index

    BMI:kg/m\*2

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    week 6

Secondary Outcomes (60)

  • Muscle grip strength test

    baseline

  • Muscle grip strength test

    week1

  • Muscle grip strength test

    week2

  • Muscle grip strength test

    week3

  • Muscle grip strength test

    week4

  • +55 more secondary outcomes

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

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.

Other: Acupuncture

Interventions

AcupunctureOTHER

Acupuncture 5 points

Acupuncture groupControl group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced esophageal cancer
  • Post feeding jejunostomy
  • Plan of CCRT for esophageal cancer

You may not qualify if:

  • Acute infection
  • Unstable vital signs
  • Other medical conditions which would affect nutrition status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37335662DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Peter Mayer

    China Medical University,Taichung, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Peiyu Kao

CONTACT

886-4-22052121D20621@mail.cmuh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2023

First Posted

April 6, 2023

Study Start

February 10, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

TW(1)