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Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical

NCT03545490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-12-18

No results posted yet for this study

Summary

The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Investigators hypothesize that early enteral nutrition intervention, which is initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added on demand during radiotherapy, will improve patients' nutritional status, tolerability to the radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of oral nutritional supplements during the course of irradiation treatment. There are two cohorts in this trial, cohort 1 included patients with oral nutritional supplements and cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy).

Conditions

  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Early nutritional intervention

Early nutritional intervention (Ensure) was given two weeks before radiotherapy. Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Principal Investigators

  • Guopei Zhu · Shanghai 9th people hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2020-10-31
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545490 on ClinicalTrials.gov