Clinical trial NCT03545490: Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malnutrition
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort 1: nutritional supplements are given through oral route Cohort 2: nutritional supplements are given by tube feeding
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: 10 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 2weeks,5 weeks, 8 weeks
measure: Body Mass Index
timeFrame: 10 weeks
measure: Calf circumference by measure
timeFrame: 5weeks, 10 weeks
measure: Lean mass measured by Bioelectrical impedance analysis (BIA)
timeFrame: 5weeks 10 weeks
measure: Fat mass measured by Bioelectrical impedance analysis (BIA)
timeFrame: 5weeks 10 weeks
measure: Patient-Generated Subjective Global Assessment/PG-SGA scores
timeFrame: 5weeks 10 weeks
measure: Dietary adherence and intake assessment
timeFrame: 2weeks,5 weeks, 8 weeks, 10 weeks
measure: Prealbumin by drawing blood
timeFrame: 5weeks 10 weeks
measure: Albumin by drawing blood
timeFrame: 5weeks 10 weeks
measure: Hemoglobin by drawing blood
timeFrame: 5weeks 10 weeks
measure: White blood cell by drawing blood
timeFrame: 5weeks 10 weeks
measure: Peripheral blood lymphocyte by drawing blood
timeFrame: 5weeks 10 weeks
measure: Tolerability to radio(chemo)therapy assessment on treatment status
timeFrame: 5 weeks, 8 weeks, 10 weeks
measure: Tolerability to radio(chemo)therapy assessment on treatment change due to side effects
timeFrame: 5 weeks, 8 weeks, 10 weeks
measure: Tolerability to radio(chemo)therapy assessment on complications
timeFrame: 5 weeks, 8 weeks, 10 weeks
measure: Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications
timeFrame: 5 weeks, 8 weeks, 10 weeks
measure: 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
timeFrame: 5 weeks, 8 weeks, 10 weeks
measure: 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
timeFrame: 5 weeks, 8 weeks, 10 weeks
measure: Health economics assessment on medications treatment due to complications
timeFrame: 10 weeks
measure: Radio(chemo)therapy treatment effect
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai 9th people hospital
name: Guopei Zhu
role: STUDY_DIRECTOR
References: