Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer

January 19, 2018 updated by: Ke-Neng Chen, MD, PhD, FRCS, Peking University Cancer Hospital & Institute
This clinical trial is designed to be a multi-center prospective observational study which shall compare the effect of different postoperative home nutrition modes on recent nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes. Different postoperative home nutrition modes adopted in this study includes oral natural diet, oral nutrition supplement and tube feeding.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on diet intake, patients with esophageal cancer are often combined with nutrition deficiency, which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al showed that the degree of body weight loss in patients with malignancy is related to BMI level and prognosis. The patients with severe body weight loss and low BMI have poor prognosis, especially for patients with esophageal cancer.

At present, perioperative nutrition support for patients with esophageal cancer has been recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good home nutrition within one month after patient discharge and recover nutrition index as soon as possible has become a focus for esophageal surgeon.

Many clinical trials have already investigated enteral nutrition support approach during anti-cancer treatment period in patients with malignancy. However, only a few clinical trials are good designed. Therefore the investigators hope to via this multi-center prospective observational study to provide evidence for this question.

OBJECTIVES:

  1. To explore the relationship between postoperative home nutrition support treatment approach and nutritional status of patients with esophageal cancer;
  2. To explore the relationship between postoperative home nutrition support treatment approach and recent prognosis in patients with esophageal cancer;
  3. To promote the standardized application of postoperative home nutrition support treatment for patients with esophageal cancer.\

OUTLINE:

Included patients shall be divided into three groups according to the treatment plan of all centers, including oral natural diet, oral nutrition supplement and tube feeding. As for patients in oral natural diet group, the patients shall receive oral natural diet. As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding enteral supplement providing 750-1500kcal/d.

All the included patients shall be followed up weekly within 1-3 weeks after discharge via telephone, at Day 30 after discharge and at Day 90 after discharge to assess the effectiveness and safety of different home nutrition supplement approaches.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • First Affiliated Hospital Bengbu Medical College
        • Contact:
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
        • Contact:
    • Beijing
      • Beijing, Beijing, China
      • Beijing, Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Union Hospital of Fujian Medical University
        • Contact:
    • Guangdong
      • Guangdong, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou General Hospital of Guangzhou Military Command
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei Medical University Fourth Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • The Third Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • AnYang Tumor Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Second Xiangya Hospital of Central South University
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Tumor Hospital & Institute
        • Contact:
          • Hongxu Liu, M.D.
          • Phone Number: +86 13840004476
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Fudan University Cancer Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Province Cancer Hospital
        • Contact:
    • Yunan
      • Kunming, Yunan, China
        • Recruiting
        • First People's Hospital of Yunan province
        • Contact:
    • Zhejiang
      • Hanzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with esophageal cancer who undergo surgery

Description

Inclusion Criteria:

  • Age below 80 years old;
  • Esophageal cancer;
  • Radical surgery;
  • Normal gastrointestinal function

Exclusion Criteria:

  • Patients with diabetes and poor blood glucose control;
  • Patients with severe postoperative complications;
  • Patients who can't tolerate lactose;
  • Patients who decline inclusion and follow-ups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Oral natural diet
As for patients in oral natural diet group, the the participants shall receive oral natural diet.
Oral nutrition supplement group
As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
Dietary supplement: Oral nutrition supplement
As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
Tube feeding nutrition supplement group
As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding nutrition supplement providing 750-1500kcal/d.
Dietary supplement: Tube feeding nutrition supplement
As for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of 5% body weight loss on Day 30
Time Frame: Day 30 after discharge
Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
Day 30 after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Completion ratio of different nutrition support approaches
Time Frame: Day 30 after discharge
Completion ratio of different nutrition support approaches
Day 30 after discharge
Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
Time Frame: Day30 and Day 90
Assessment on patients' quality of life using EORTC QLQ-C30 scale and QLQ-OG25 scale in different nutrition support approach groups and investigate the relationship between different nutrition support approaches and patients' quality of life
Day30 and Day 90
Complications of home enteral nutrition support
Time Frame: Day30
Assessment on complications of home enteral nutrition support
Day30
Delay and interruption ratio of adjuvant treatment
Time Frame: Day 30 and Day 90
Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time
Day 30 and Day 90
Re-hospitalization ratio
Time Frame: Day 90
Re-hospitalization ratio within 90 days after discharge
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Cancer Hospital & Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Cancer Hospital
Shanxi Province Cancer Hospital
The First Affiliated Hospital of Anhui Medical University
Sun Yat-sen University
Fudan University
Fujian Cancer Hospital
Chinese PLA General Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Shandong Provincial Hospital
Shanghai Chest Hospital
China-Japan Friendship Hospital
The First Hospital of Jilin University
Hunan Provincial People's Hospital
Hebei Medical University Fourth Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Second Xiangya Hospital of Central South University
First Affiliated Hospital Bengbu Medical College
Liaoning Tumor Hospital & Institute
Anyang Tumor Hospital
The Third Affiliated Hospital of Harbin Medical University
Wuhan General Hospital of Guangzhou Military Command
Union hospital of Fujian Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keneng Chen, M.D., Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-06-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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