Esophageal CancerNCT06275165
The Effects of Acupressure on Improving Postoperative Gastrointestinal Symptom Distress in Esophageal Cancer Patients
A study testing acupressure in people with Esophageal Cancer and Gastrointestinal Dysfunction, run by CHEN, CHIA-CHEN at 1 site in Taiwan.
Trial summary
This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Cancer, Gastrointestinal Dysfunction
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Mar 2024to 18 Jul 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized men and women who agree to participate in this study
- Patients diagnosed with esophageal cancer based on pathological tissue section results
- Nutritional support through jejunostomy in post esophagectomy patients
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
Who cannot join
- Pregnant or lactating women
- Diagnosed and treated for peripheral vascular disease within 3 months prior to surgery.
- Those with unstable vital signs and septicemia infection after surgery.
- Those who are suffering from blood diseases with abnormal coagulation function, or Currently taking anticoagulant drugs.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Patients in the experimental group received routine care and acupressure for 5 consecutive days starting from the day after entering the ward after esophageal cancer surgery, in the control group, participants received routine care, and Participants were assessed on the Gastrointestinal Symptom Distress Scale at the end of the intervention. The aim of this study was to verify the effectiveness of acupressure in improving of gastrointestinal symptoms distress after esophageal cancer surgery.
Read the detailed description
Esophageal cancer is one of the common and highly fatal malignant tumors, and its incidence rate is increasing every year, and most of them are in the middle and advanced stages when diagnosed. Surgery is the standard treatment for the eradication of esophageal cancer, which can effectively reduce the mortality rate and improve the survival rate, but the patients often experience gastrointestinal discomfort after surgery, which impedes the intake of nutrients and the body's recovery. The purpose of this study was to investigate the effectiveness of acupressure in improving the postoperative gastrointestinal discomfort in patients with esophageal cancer. An experimental study design was adopted, and patients were assigned to the experimental group and the control group in a time-divided manner. The experimental group was assigned to the experimental group and the control group in a time-separated manner. The experimental group received regular care from the first day to the fifth day after the patients were transferred from the intensive care unit to the hospital ward after the surgery, and they received acupressure at the Neiguan point of the upper limbs and the four acupoints of the foot Sanli of the lower limbs twice a day for 3 minutes each, for a total of 12 minutes; while the control group received regular care in the first day of the study. In this study, the gastrointestinal symptoms of the experimental group before and after acupressure were collected and compared with those of the control group, in order to verify the effectiveness of acupressure in improving gastrointestinal symptoms during postoperative nutritional support for jejunostomy.
- Conditions
- Esophageal Cancer, Gastrointestinal Dysfunction
- Being tested
- acupressure
- Keywords
- gastrointestinal symptom distress, acupressure
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
In the experimental group, routine nursing care and acupressure (Neiguan and Zusanli points) were performed from the 1st to the 5th day after the postoperative transfer from the ward to the hospital room. Twice a day, 3 minutes each time, 12 minutes in total.
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | Participants received routine care and acupressure. Receives: Other: acupressure |
| no intervision | No intervention | received routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in gastrointestinal symptom distress Scale at study day 5(end day)
The Gastrointestinal Symptom Distress Scale is a validated self-report tool that assesses 10 gastrointestinal symptoms that patients with esophageal cancer may face after surgery. The 10-question questionnaire measures the self-perceived severity of nausea, vomiting, satiety, bloating, abdominal cramps, acid reflux, chest tightness, heart burn, diarrhea, and constipation, as well as the degree of interference with life. Using an 11-point Likert scale, 0 points (never happened), 1 point (very slight/very slight interference), 10 points (very severe/extreme interference), and the total score of the scale is 0-100 points.
The higher the measured score, the more severe the gastrointestinal discomfort symptoms are and the more they interfere with life.
The Gastrointestinal Symptom Distress Scale was subjected to an expert validity review, using the CVI (content validity index) calculation method, and the score was above 0.80.
Measured: Baseline and study day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start27 Mar 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were divided into an experimental group and a control group. experimental group: received acupressure for 5 days in addition to regular care. control group: received regular postoperative care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEN, CHIA-CHEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHEN, CHIA-CHEN, Chang Gung Memorial Hospital
- Investigators
- Chia-Chen Chen, Principal investigator, Chang Gung Memorail Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275165
- Sponsor's protocol ID
- 202301754B0
- Status last verified
- Aug 2025
- First submitted
- 17 Feb 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupressure on Improving Postoperative Gastrointestinal Symptom Distress in Esophageal Cancer Patients
- ClinicalTrials.gov ID
- NCT06275165
- Acronym / sponsor ID
- 202301754B0
- Conditions
- Esophageal Cancer, Gastrointestinal Dysfunction
- Keywords
- gastrointestinal symptom distress, acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CHEN, CHIA-CHENUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 23 Feb 2024 (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.
This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Patients in the experimental group received routine care and acupressure for 5 consecutive days starting from the day after entering the ward after esophageal cancer surgery, in the control group, participants received routine care, and Participants were assessed on the Gastrointestinal Symptom Distress Scale at the end of the intervention. The aim of this study was to verify the effectiveness of acupressure in improving of gastrointestinal symptoms distress after esophageal cancer surgery.
Detailed description
Esophageal cancer is one of the common and highly fatal malignant tumors, and its incidence rate is increasing every year, and most of them are in the middle and advanced stages when diagnosed. Surgery is the standard treatment for the eradication of esophageal cancer, which can effectively reduce the mortality rate and improve the survival rate, but the patients often experience gastrointestinal discomfort after surgery, which impedes the intake of nutrients and the body's recovery. The purpose of this study was to investigate the effectiveness of acupressure in improving the postoperative gastrointestinal discomfort in patients with esophageal cancer. An experimental study design was adopted, and patients were assigned to the experimental group and the control group in a time-divided manner. The experimental group was assigned to the experimental group and the control group in a time-separated manner. The experimental group received regular care from the first day to the fifth day after the patients were transferred from the intensive care unit to the hospital ward after the surgery, and they received acupressure at the Neiguan point of the upper limbs and the four acupoints of the foot Sanli of the lower limbs twice a day for 3 minutes each, for a total of 12 minutes; while the control group received regular care in the first day of the study. In this study, the gastrointestinal symptoms of the experimental group before and after acupressure were collected and compared with those of the control group, in order to verify the effectiveness of acupressure in improving gastrointestinal symptoms during postoperative nutritional support for jejunostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were divided into an experimental group and a control group. experimental group: received acupressure for 5 days in addition to regular care. control group: received regular postoperative care.
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: acupressureParticipants received routine care and acupressure. |
| no intervision | No intervention | –received routine care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized men and women who agree to participate in this study
- Patients diagnosed with esophageal cancer based on pathological tissue section results
- Nutritional support through jejunostomy in post esophagectomy patients
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Diagnosed and treated for peripheral vascular disease within 3 months prior to surgery.
- Those with unstable vital signs and septicemia infection after surgery.
- Those who are suffering from blood diseases with abnormal coagulation function, or Currently taking anticoagulant drugs.
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 |
|---|---|---|
| acupressureIn the experimental group, routine nursing care and acupressure (Neiguan and Zusanli points) were performed from the 1st to the 5th day after the postoperative transfer from the ward to the hospital room. Twice a day, 3 minutes each time, 12 minutes in total. | Other | acupressure |
Primary outcome
Change from Baseline in gastrointestinal symptom distress Scale at study day 5(end day)
Time frame: Baseline and study day 5
The Gastrointestinal Symptom Distress Scale is a validated self-report tool that assesses 10 gastrointestinal symptoms that patients with esophageal cancer may face after surgery. The 10-question questionnaire measures the self-perceived severity of nausea, vomiting, satiety, bloating, abdominal cramps, acid reflux, chest tightness, heart burn, diarrhea, and constipation, as well as the degree of interference with life. Using an 11-point Likert scale, 0 points (never happened), 1 point (very slight/very slight interference), 10 points (very severe/extreme interference), and the total score of the scale is 0-100 points. The higher the measured score, the more severe the gastrointestinal discomfort symptoms are and the more they interfere with life. The Gastrointestinal Symptom Distress Scale was subjected to an expert validity review, using the CVI (content validity index) calculation method, and the score was above 0.80.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Chia-Chen Chen principal investigator
Chang Gung Memorail Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Esophageal Cancer and Gastrointestinal Dysfunction, run by CHEN, CHIA-CHEN 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 7 Aug 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in gastrointestinal symptom distress Scale at study day 5(end day) (time frame: Baseline and study day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2025.