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

A Prospective, Randomized, Clinical Study to Evaluate the Effects of Early Enteral Nutritional Supplementation on Clinical Outcomes in Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical Resection

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).

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Early nutritional intervention

Detailed Description

This clinical trial will be conducted in a single-center, prospective, and randomized manner. In this protocol, the standard radio(chemo)therapy duration is 6-7 weeks. Early enteral nutrition intervention (EEN) refers to starting enteral nutrition intervention 2 weeks before post-operative radio(chemo)therapy begins and stopping this intervention when post-operative radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to starting of enteral nutrition intervention on demand during (chemo)radiotherapy. Nutritional supplementation was given either through the oral route (Cohort 1) or tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy, cohort 2). Dietitians will design meal plans for both groups of subjects so that their normal diets will provide 25-30 kcal/d/kg body weight in addition to nutritional supplements.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rongrong LI; Phone Number: 86 15801985171; Email: rongrli2003@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Subject is male or female, between 18 and 70 years old;
• Subject has clinical or radiological diagnosis of oral cancer (stage III and stage IV), had surgical resection 3 or 4 weeks prior to radio (chemo)therapy, and plans to receive radio (chemo)therapy treatment;
• Subject has Karnofsky Performance Score (KPS) ≥ 60 and an expected life expectancy ≥ 6 months;
• Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol;
• Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study

Exclusion criteria

• Except for oral cancer and oropharyngeal cancer, subject has malignant tumors or serious infectious diseases, such as tuberculosis activity, respiratory system, cardiovascular system, urinary system diseases, systemic edema and ascites caused by diseases, etc., cannot participant in study in the opinion of study physician.
• Subject has dysfunction of liver, kidney or gallbladder, cannot participant in study in the opinion of study physician.
• Subject has gastrointestinal diseases to cannot tolerate enteral nutrition (such as intestinal bleeding, intestinal obstruction, severe digestive malabsorption, severe nausea and vomiting and diarrhea) that preclude his or her participation in the opinion of study physician;
• Subject has diabetes
• Subject has known history of allergy or intolerance to any ingredient in the investigational product;
• Female subjects are pregnant or plan to get pregnant within a year or are postpartum and non-lactating;
• Subject has mental illness, cannot understand ICF, unwilling to provide informed consent.
• Subject has amputation or implanted electronic devices or metal, it may be inappropriate to use BIA to measure body composition
• Subject is currently or has participated in any clinical trial 2 months prior to enrollment.
• Subject plans to take nutritional supplements and/or traditional Chinese medicine regularly during study in the opinion of study physician. Multi-vitamin and multi-mineral supplements are exception.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1-intervention; Oral supplements are given through oral route 2 weeks before radiotherapy.	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.
Active Comparator: Cohort 1-Control; Oral supplements are given through oral route on demand during radiotherapy.	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.
Experimental: Cohort 2- Intervention; Oral supplements are given by tube feeding 2 weeks before radiotherapy.	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.
Active Comparator: Cohort 2- Control; Oral supplements are given by tube feeding on demand during radiotherapy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	changes of body weight from baseline to Final Visit/Exit.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Changes of body weight from baseline to V2, V3 and V4	2weeks,5 weeks, 8 weeks
Body Mass Index	Body Mass Index variables at baseline to V2, V3,V4 and Final Visit/Exit	10 weeks
Calf circumference by measure	Calf circumference variables at baseline to V3 and Final Visit/Exit	5weeks, 10 weeks
Lean mass measured by Bioelectrical impedance analysis (BIA)	Lean mass variables at baseline, V3 and Final Visit/Exit	5weeks 10 weeks
Fat mass measured by Bioelectrical impedance analysis (BIA)	Fat mass variables at baseline, V3 and Final Visit/Exit	5weeks 10 weeks
Patient-Generated Subjective Global Assessment/PG-SGA scores	PG-SGA scores, an assessment tool for nutritional status at baseline, V3 and Final Visit/Exit. The Scored PG-SGA includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function), the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished), the total numerical score, and nutritional triage Recommendations (0-1=No intervention required, 2-3 Education and lab values as appropriate, 4-8 Required intervention, >=9 Indicates a critical need for improved and/or nutrient intervention). Subtotal 4 historical components: scoring 0-30+; Weight history and Symptoms scores are additive; Food intake and Activities and Function, the highest point score, Professional component: Criteria for condition, scoring 0-6; Metabolic Stress, scoring 0-3; Physical components, scoring 0-3	5weeks 10 weeks
Dietary adherence and intake assessment	Dietary adherence and intake assessment will be conducted by dietitians at V2, V3, V4 and Final Visit/Exit. Dietary adherence will be determined through comparing subjects' meal plans and actual consumptions as reflected by food diaries.	2weeks,5 weeks, 8 weeks, 10 weeks
Prealbumin by drawing blood	Prealbumin variables at baseline, V3 and Final Visit/Exit	5weeks 10 weeks
Albumin by drawing blood	Albumin variables at baseline, V3 and Final Visit/Exit	5weeks 10 weeks
Hemoglobin by drawing blood	Hemoglobin variables at baseline, V3 and Final Visit/Exit	5weeks 10 weeks
White blood cell by drawing blood	White blood cell variables at baseline, V3 and Final Visit/Exit	5weeks 10 weeks
Peripheral blood lymphocyte by drawing blood	Peripheral blood lymphocyte variables at baseline, V3 and Final Visit/Exit	5weeks 10 weeks
Tolerability to radio(chemo)therapy assessment on treatment status	Treatment status (e.g., treatment course and doses completed as planned or changed) since last visit at V3, V4 and Final Visit/Exit	5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on treatment change due to side effects	Number of days when treatment is suspended due to side effects since last visit at V3, V4 and Final Visit/Exit	5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on complications	Incidence of radio(chemo)therapy-related complications such as oral mucositis, pneumonia, and shingles since last visit at V3, V4 and Final Visit/Exit	5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications	Number of days when patients stay in hospital for treatment of radio(chemo)therapy-related complications since last visit at V3, V4 and Final Visit/Exit (if applicable)	5 weeks, 8 weeks, 10 weeks
Quality of life assessed by Quality of Life Questionnaire-Core 36 of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-C30 questionnaire	Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-C30 questionnaire at baseline, V3, V4 and Final Visit/Exit	5 weeks, 8 weeks, 10 weeks
Quality of life assessed by Quality of Life Questionnaire-Head and Neck 35 questionnaire of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-H&N35	Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-H&N35 questionnaire at baseline, V3, V4 and Final	5 weeks, 8 weeks, 10 weeks
Health economics assessment on medications treatment due to complications	Costs for medications treated for radio(chemo)therapy-related complications during this study	10 weeks
Radio(chemo)therapy treatment effect	The variable is local tumor control probability assessed at baseline and Final Visit/Exit. Local tumor control probability is defined as the percentage of patients who do not have tumor recurrence in the total patients.	10 weeks

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Director: Guopei Zhu, Shanghai 9th People hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Nutrition Disorders; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Malnutrition; Oropharyngeal Neoplasms
• Other Study ID Numbers: ANCH 1601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No