Esophageal CancerNCT06652620
Cola Ingestion for Esophageal Bolus Impaction
A study testing Cola in people with Esophageal Cancer, run by Fudan University at 5 sites in China.
Trial summary
The aim of the study is to observe whether cola ingestion can improve the 24-hour remission rate of acute esophageal impaction in patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Cola
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesChina
- Study dates
- 1 Nov 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary esophageal lesions diagnosed by pathology, being able to consume at least a liquid diet normally before and diagnosed by a physician with acute esophageal impaction (acute esophageal impaction refers to the sudden occurrence of complete obstruction of eating within the past week)
- Prior to enrollment, the patient did not consume carbonated beverages such as cola, or any other treatment for esophageal impaction.
- Age ≥ 18 years old, Eastern Cooperative Oncology Group (ECOG) Performance Status score is 0-2 points.
- The subjects voluntarily enrolled and obtained an informed consent form signed by the patient or their legal representative.
Who cannot join
- It is known that complete esophageal obstruction is caused by tumor progression.
- Patients who have been diagnosed with or highly suspected of having esophageal fistula through endoscopy or imaging prior to enrollment.
- Patients with nasogastric nutrition tube and esophageal stent implantation
- Patients who have symptoms such as coughing and are unable to drink cola, or who are at serious risk of aspiration (Glasgow Coma Scale<14 or previous history of aspiration).
- Benign diseases such as gastroesophageal reflux, cardiac arrest, and congenital esophageal stenosis that can easily lead to foreign body impaction in the esophagus.
- Patients with coagulation dysfunction, thrombocytopenia, or taking anticoagulant drugs that are medically considered contraindications for endoscopic examination and treatment.
- According to the researchers' assessment, patients may not be able to cooperate with the examination and treatment, or there may be other factors that could force them to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concomitant treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the patients or the collection of experimental data.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Anyang tumor hospital
Anyang, Henan
First People's Hospital
Jingdezhen, Jiangxi
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xiamen University Affiliated First Hospital (Haicang Campus), Xiamen Cancer Hospital
Xiamen, Fujian
The Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
About this study
Official title: Oral Cola for Acute Food Bolus Impaction in Patients With Esophageal Cancer: a Prospective, Randomized Proof-of-concept Study
The aim of the study is to observe whether cola ingestion can improve the 24-hour remission rate of acute esophageal impaction in patients with esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Cola
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColaOther
regular Coca-Cola (Coca-Cola company, Atlanta, GA) or Pesi-cola (PepsiCo, Inc.New York, NY)
| Study group | Role | What they receive |
|---|---|---|
| Cola ingestion group | Experimental | Participants in the intervention group are instructed to consume regular Cola in an upright or sitting position after diagnosing with a complete esophageal bolus impaction. Receives: Other: Cola |
| Control group | No intervention | Patients in the control group did not receive any pre-endoscopic treatment.This arm includes participants only from Stage 1 (Randomized Phase) of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour remission rate of acute esophageal impaction
The percentage corresponding to the ratio of the number of patients who achieved relief of esophageal impaction (including partial and complete relief) within 24 hours to the total number of patients in the group is the 24-hour relief rate.
Measured: The observation interval is from the diagnosis of esophageal impaction and random onset to the relief of esophageal impaction (at least allowing smooth consumption of liquid food) or the first 24-hour interval after diagnosis of esophageal impaction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Feb 2026
- Study completion30 Jun 2027 (estimated)
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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 patients randomized 1:1 to oral cola vs control (parallel assignment, open-label, blinded outcome assessment); primary endpoint: 24-hour relief rate.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652620
- Sponsor's protocol ID
- ESO-Shanghai24
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Cola for Acute Food Bolus Impaction in Patients With Esophageal Cancer: a Prospective, Randomized Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06652620
- Acronym / sponsor ID
- ESO-Shanghai24
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Oct 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.
The aim of the study is to observe whether cola ingestion can improve the 24-hour remission rate of acute esophageal impaction in patients with esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 patients randomized 1:1 to oral cola vs control (parallel assignment, open-label, blinded outcome assessment); primary endpoint: 24-hour relief rate.
| Arm | Type | Receives |
|---|---|---|
| Cola ingestion group | Experimental | Other: ColaParticipants in the intervention group are instructed to consume regular Cola in an upright or sitting position after diagnosing with a complete esophageal bolus impaction. |
| Control group | No intervention | –Patients in the control group did not receive any pre-endoscopic treatment.This arm includes participants only from Stage 1 (Randomized Phase) of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with primary esophageal lesions diagnosed by pathology, being able to consume at least a liquid diet normally before and diagnosed by a physician with acute esophageal impaction (acute esophageal impaction refers to the sudden occurrence of complete obstruction of eating within the past week)
- Prior to enrollment, the patient did not consume carbonated beverages such as cola, or any other treatment for esophageal impaction.
- Age ≥ 18 years old, Eastern Cooperative Oncology Group (ECOG) Performance Status score is 0-2 points.
- The subjects voluntarily enrolled and obtained an informed consent form signed by the patient or their legal representative.
Key exclusion criteria (7 listed)
- It is known that complete esophageal obstruction is caused by tumor progression.
- Patients who have been diagnosed with or highly suspected of having esophageal fistula through endoscopy or imaging prior to enrollment.
- Patients with nasogastric nutrition tube and esophageal stent implantation
- Patients who have symptoms such as coughing and are unable to drink cola, or who are at serious risk of aspiration (Glasgow Coma Scale<14 or previous history of aspiration).
- Benign diseases such as gastroesophageal reflux, cardiac arrest, and congenital esophageal stenosis that can easily lead to foreign body impaction in the esophagus.
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 |
|---|---|---|
| Colaregular Coca-Cola (Coca-Cola company, Atlanta, GA) or Pesi-cola (PepsiCo, Inc.New York, NY) | Other | Cola ingestion group |
Primary outcome
24-hour remission rate of acute esophageal impaction
Time frame: The observation interval is from the diagnosis of esophageal impaction and random onset to the relief of esophageal impaction (at least allowing smooth consumption of liquid food) or the first 24-hour interval after diagnosis of esophageal impaction.
The percentage corresponding to the ratio of the number of patients who achieved relief of esophageal impaction (including partial and complete relief) within 24 hours to the total number of patients in the group is the 24-hour relief rate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cola in people with Esophageal Cancer, run by Fudan University at 5 sites in China.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
24-hour remission rate of acute esophageal impaction (time frame: The observation interval is from the diagnosis of esophageal impaction and random onset to the relief of esophageal impaction (at least allowing smooth consumption of liquid food) or the first 24-hour interval after diagnosis of esophageal impaction.). 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 23 Sep 2026.