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Completed

NCT Number: NCT04199832

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

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).

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Chemoradiotherapy Digestive System Diseases Digestive System Neoplasms Enteral Nutrition Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Tianjin, Tianjin Municipality, 300000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary guidance

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Blood biochemical examination

    Time frame: up to 1 month after the treatment

    albumin,prealbumin,haemoglobin,et al, record the changes before and after the treatment.

  2. Scored Patient-Generated Subjective Global Assessment (PG-SGA)

    Time frame: up to 1 month after the treatment

    Nutritional status evaluation table. score: 0-1 A: well-nourished; score：2-8 B: moderately malnourished; score：≥9 C: severely malnourished.

  3. EORTC QLQ-C30

    Time frame: up to 1 month after the treatment

    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.

  4. Grade 3-5 toxicity

    Time frame: up to 1 month after the treatment

    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

  5. Completion rate of chemoradiotherapy

    Time frame: up to 1 month after the treatment

    The proportion of people who complete all treatment as required

  6. Overall Survival

    Time frame: at least 2 years

    overall survival

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2019
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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