NCT04199832

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 2, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

December 20, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 16, 2023

Status Verified

September 1, 2022

Enrollment Period

2.5 years

First QC Date

December 2, 2019

Last Update Submit

February 14, 2023

Conditions

Esophageal Squamous Cell CarcinomaChemoradiotherapyEnteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 1 month after the treatment

Secondary Outcomes (6)

  • Blood biochemical examination

    up to 1 month after the treatment

  • Scored Patient-Generated Subjective Global Assessment (PG-SGA)

    up to 1 month after the treatment

  • EORTC QLQ-C30

    up to 1 month after the treatment

  • Grade 3-5 toxicity

    up to 1 month after the treatment

  • Completion rate of chemoradiotherapy

    up to 1 month after the treatment

  • +1 more secondary outcomes

Study Arms (3)

Nasogastric tube

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

Dietary Supplement: Dietary guidance

gastrostomy feeding

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

Dietary Supplement: Dietary guidance

Oral intake

Patients with normal swallowing or not receiving tube feeding.

Dietary Supplement: Dietary guidance

Interventions

Dietary guidanceDIETARY_SUPPLEMENT

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

Nasogastric tubeOral intakegastrostomy feeding

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with esophageal squamous cell carcinoma who received concurrent chemoradiotherapy voluntarily chose different nutritional treatment paths according to the degree of dysphagia.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (1)

  • 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.

    PMID: 37150411DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Qingsong Pang, Doctor

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 16, 2019

Study Start

December 20, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 16, 2023

Record last verified: 2022-09

Locations

CN(1)