Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical
- Conditions
- Malnutrition
- Interventions
- Dietary Supplement: Early nutritional intervention
- Registration Number
- NCT03545490
- Lead Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1-intervention Early nutritional intervention Oral supplements are given through oral route 2 weeks before radiotherapy. Cohort 1-Control Early nutritional intervention Oral supplements are given through oral route on demand during radiotherapy. Cohort 2- Intervention Early nutritional intervention Oral supplements are given by tube feeding 2 weeks before radiotherapy. Cohort 2- Control Early nutritional intervention Oral supplements are given by tube feeding on demand during radiotherapy.
- Primary Outcome Measures
Name Time Method Body weight 10 weeks changes of body weight from baseline to Final Visit/Exit.
- Secondary Outcome Measures
Name Time Method Radio(chemo)therapy treatment effect 10 weeks 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.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 5 weeks, 8 weeks, 10 weeks 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
Health economics assessment on medications treatment due to complications 10 weeks Costs for medications treated for radio(chemo)therapy-related complications during this study
Body weight 2weeks,5 weeks, 8 weeks Changes of body weight from baseline to V2, V3 and V4
Hemoglobin by drawing blood 5weeks 10 weeks Hemoglobin variables at baseline, V3 and Final Visit/Exit
White blood cell by drawing blood 5weeks 10 weeks White blood cell variables at baseline, V3 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on complications 5 weeks, 8 weeks, 10 weeks Incidence of radio(chemo)therapy-related complications such as oral mucositis, pneumonia, and shingles since last visit at V3, V4 and Final Visit/Exit
Body Mass Index 10 weeks Body Mass Index variables at baseline to V2, V3,V4 and Final Visit/Exit
Calf circumference by measure 5weeks, 10 weeks Calf circumference variables at baseline to V3 and Final Visit/Exit
Lean mass measured by Bioelectrical impedance analysis (BIA) 5weeks 10 weeks Lean mass variables at baseline, V3 and Final Visit/Exit
Patient-Generated Subjective Global Assessment/PG-SGA scores 5weeks 10 weeks 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 0-3Dietary adherence and intake assessment 2weeks,5 weeks, 8 weeks, 10 weeks 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.
Prealbumin by drawing blood 5weeks 10 weeks Prealbumin variables at baseline, V3 and Final Visit/Exit
Fat mass measured by Bioelectrical impedance analysis (BIA) 5weeks 10 weeks Fat mass variables at baseline, V3 and Final Visit/Exit
Albumin by drawing blood 5weeks 10 weeks Albumin variables at baseline, V3 and Final Visit/Exit
Peripheral blood lymphocyte by drawing blood 5weeks 10 weeks Peripheral blood lymphocyte variables at baseline, V3 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on treatment status 5 weeks, 8 weeks, 10 weeks Treatment status (e.g., treatment course and doses completed as planned or changed) since last visit at V3, V4 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on treatment change due to side effects 5 weeks, 8 weeks, 10 weeks Number of days when treatment is suspended due to side effects since last visit at V3, V4 and Final Visit/Exit
Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications 5 weeks, 8 weeks, 10 weeks 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)
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 5 weeks, 8 weeks, 10 weeks 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
Trial Locations
- Locations (1)
Shanghai ninth people's hospital
🇨🇳Shanghai, Shanghai, China