To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy

NCT ID: NCT04199832

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-20

Study Completion Date

2022-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma Chemoradiotherapy Enteral Nutrition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Nasogastric tube

The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube.

Dietary guidance

Intervention Type DIETARY_SUPPLEMENT

Dietary guidance for feeding tube patients with food homogenate,dietary guidance for patients with oral feeding.

gastrostomy feeding

Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding.

Dietary guidance

Intervention Type DIETARY_SUPPLEMENT

Dietary guidance for feeding tube patients with food homogenate,dietary guidance for patients with oral feeding.

Oral intake

Patients with normal swallowing or not receiving tube feeding.

Dietary guidance

Intervention Type DIETARY_SUPPLEMENT

Dietary guidance for feeding tube patients with food homogenate,dietary guidance for patients with oral feeding.

Interventions

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Dietary guidance

Dietary guidance for feeding tube patients with food homogenate,dietary guidance for patients with oral feeding.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qingsong Pang, Doctor

Role: STUDY_CHAIR

Department of Radiation Oncology,Tianjin Medical University cancer Institute and Hospital

Locations

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Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37150411 (View on PubMed)

Other Identifiers

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20190920

Identifier Type: -

Identifier Source: org_study_id

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