Esophageal Squamous Cell CarcinomaNCT04199832
To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy
An observational study of Esophageal Squamous Cell Carcinoma and Chemoradiotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study prospectively recruited esophageal squamous-cell carcinoma patients who received nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in nutritional status and quality of life during chemoradiation therapy (CRT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Enteral Nutrition
- What is being tested?
- Dietary guidance
- Type of treatment
- Pill or oral medicine
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2019to 30 Jun 2022
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal squamous cell carcinoma who received concurrent chemoradiotherapy voluntarily chose different nutritional treatment paths according to the degree of dysphagia.
Who may be able to join
- Pathologically or cytologically proven esophageal squamous cell carcinoma
- Karnofsky performance score(KPS) ≧70
- Concurrent chemoradiotherapy
- Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Patients have good compliance to treatment and follow-up of acceptance
- the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications
Who cannot join
- Patients with severely bowel function impaired or can not tolerate enteral nutrition
- Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
- Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
- Patients who have distant metastasis
- The primary tumor or lymph node already received surgical treatment efuse or incapable to sign the informed consent form of participating this trial
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: Nutritional Status and Complications in Patients Undergoing Chemoradiotherapy for Esophageal Squamous Cell Carcinomas: a Comparison of Nasogastric Tube, Percutaneous Endoscopic Gastrostomy Tube and Oral Supplement
This study prospectively recruited esophageal squamous-cell carcinoma patients who received nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in nutritional status and quality of life during chemoradiation therapy (CRT).
- Being tested
- Dietary guidance
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary guidanceDietary supplement
Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric tube | The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube. Receives: Dietary Supplement: Dietary guidance | |
| gastrostomy feeding | Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding. Receives: Dietary Supplement: Dietary guidance | |
| Oral intake | Patients with normal swallowing or not receiving tube feeding. Receives: Dietary Supplement: Dietary guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Change from baseline to the end of treatment
Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.
Measured: up to 1 month after the treatment
Secondary outcomes (6)
Blood biochemical examination
albumin,prealbumin,haemoglobin,et al, record the changes before and after the treatment.
Measured: up to 1 month after the treatment
Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Nutritional status evaluation table. score: 0-1 A: well-nourished; score：2-8 B: moderately malnourished; score：≥9 C: severely malnourished.
Measured: up to 1 month after the treatment
EORTC QLQ-C30
Quality of life evaluation form. QLQ-C30 results were linearly transformed to scores 0 to 100. Higher scores represent worse symptoms in the symptom scales and better function in functional scales.
Measured: up to 1 month after the treatment
Grade 3-5 toxicity
Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ，such as esophagitis、pneumonitis 、hematologic toxicity and infection rate
Measured: up to 1 month after the treatment
Completion rate of chemoradiotherapy
The proportion of people who complete all treatment as required
Measured: up to 1 month after the treatment
Overall Survival
overall survival
Measured: at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start20 Dec 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Esophageal Squamous Cell CarcinomaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingsong Pang, Doctor, Study chair, Department of Radiation Oncology,Tianjin Medical University cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199832
- Sponsor's protocol ID
- 20190920
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dong J, Dai Z, Cao F, Zhang W, Zhang T, Chen X, Chen Y, Zhao F, Li J, Du Q, Zhang K, Zeng Y, Li C, Wang Y, Li Y, Wang K, Pang Q. Effects of PEG in patients with esophageal squamous cell carcinoma during concurrent chemoradiotherapy: a prospective study. Gastrointest Endosc. 2023 Dec;98(6):901-910.e3. doi: 10.1016/j.gie.2023.04.2094. Epub 2023 May 5.
PubMed 37150411
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Complications in Patients Undergoing Chemoradiotherapy for Esophageal Squamous Cell Carcinomas: a Comparison of Nasogastric Tube, Percutaneous Endoscopic Gastrostomy Tube and Oral Supplement
- ClinicalTrials.gov ID
- NCT04199832
- Acronym / sponsor ID
- 20190920
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Dec 2019 (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 prospectively recruited esophageal squamous-cell carcinoma patients who received nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in nutritional status and quality of life during chemoradiation therapy (CRT).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasogastric tube | – | Dietary Supplement: Dietary guidanceThe patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube. |
| gastrostomy feeding | – | Dietary Supplement: Dietary guidancePatients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding. |
| Oral intake | – | Dietary Supplement: Dietary guidancePatients with normal swallowing or not receiving tube feeding. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal squamous cell carcinoma who received concurrent chemoradiotherapy voluntarily chose different nutritional treatment paths according to the degree of dysphagia.
Key inclusion criteria (8 listed)
- Pathologically or cytologically proven esophageal squamous cell carcinoma
- Karnofsky performance score(KPS) ≧70
- Concurrent chemoradiotherapy
- Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
Key exclusion criteria (5 listed)
- Patients with severely bowel function impaired or can not tolerate enteral nutrition
- Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
- Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
- Patients who have distant metastasis
- The primary tumor or lymph node already received surgical treatment efuse or incapable to sign the informed consent form of participating this trial
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 |
|---|---|---|
| Dietary guidanceDietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding. | Dietary supplement | Nasogastric tube, Oral intake, gastrostomy feeding |
Primary outcome
Body Weight Change from baseline to the end of treatment
Time frame: up to 1 month after the treatment
Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.
6 secondary outcomes
Blood biochemical examination
Time frame: up to 1 month after the treatment
Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: up to 1 month after the treatment
EORTC QLQ-C30
Time frame: up to 1 month after the treatment
Grade 3-5 toxicity
Time frame: up to 1 month after the treatment
Completion rate of chemoradiotherapy
Time frame: up to 1 month after the treatment
Overall Survival
Time frame: at least 2 years
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 16 Feb 2023.
- Derived from this study: PubMed 37150411Dong J, Dai Z, Cao F, Zhang W, Zhang T, Chen X, Chen Y, Zhao F, Li J, Du Q, Zhang K, Zeng Y, Li C, Wang Y, Li Y, Wang K, Pang Q. Effects of PEG in patients with esophageal squamous cell carcinoma during concurrent chemoradiotherapy: a prospective study. Gastrointest Endosc. 2023 Dec;98(6):901-910.e3. doi: 10.1016/j.gie.2023.04.2094. Epub 2023 May 5.
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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.
Qingsong Pang, Doctor study chair
Department of Radiation Oncology,Tianjin Medical University cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma and Chemoradiotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 8 inclusion and 5 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 16 Feb 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 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?
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?
Body Weight Change from baseline to the end of treatment (time frame: up to 1 month after the treatment). 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 NCT04199832, 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 16 Feb 2023.