Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Nedaplatin

Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Energy goal: daily total nutritional intake of about 30 kcal/kg.

Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.

Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.

Early Nutrition Intervention from the start of CCRT

Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy

Thoracic radiotherapy

Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy

Weekly DP chemotherapy concurrent with thoracic radiotherapy

Hui Liu, Professor

This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.

This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.

Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Weekly counseling sessions, conducted by both doctors and nurses, aimed to educate patients on regulating their regular dietary intake to meet specific energy, protein, and other macronutrient requirements. Dietary advice provided precise instructions on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily energy intake of approximately 30 kcal/kg. All patients received definitive thoracic radiotherapy with total radiation doses of 60-68 Gy, concurrent with weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡).

Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

The association between oral nutritional supplements outcome and the gut microbiota.

The proportion of patients experiencing a weight loss of 5% or more during the CCRT

Nutrition-related parameters, including weight, body mass index (BMI), hemoglobin (HGB), serum albumin (ALB), pre-albumin (PA), lymphocyte (LY)

Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis.

Including overall survival and progression-free survival.

Sun Yat-sen University

Professor

Nutritional and Metabolic Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Malnutrition

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nutrition Disorders

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Patients in early ONS intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy) and ONS intervention in the beginning of radiotherapy. The ONS is prescribed to increase oral intake of patients and to ensure total energy supply is more than 30 kcal/kg/day and protein intake more than 1.2 g/kg/day.

Patients in standard nutrition intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy).

Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.

oral nutritional supplements

Yi Pan, Prof.

Yi Pan, Dr.

This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.

Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated with adverse clinical outcomes. Although patients receive conventional nutritional intervention recommended by The European Society for Clinical Nutrition and Metabolism guidelines, there are still 35% NPC patients suffering from malnutrition during chemoradiotherapy.

Recent studies have shown that early nutritional intervention before radiotherapy reduced the prevalence of malnutrition. However, there are few randomized controlled clinical studies comparing early oral nutritional supplements (ONS) intervention to conventional nutritional intervention in NPC patients undergoing chemoradiotherapy.

This single center, open-label, randomized controlled clinical trial was designed to investigate whether early ONS intervention compared to conventional nutritional intervention improves nutritional status, treatment tolerance and quality of life, and decreases the incidence of grade 3-4 treatment related side-effects in NPC patients undergoing chemoradiotherapy.

Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

A Randomized Controlled Trial of an Early Oral Nutritional Supplements Intervention Versus a Conventional Nutritional Intervention in Patients With Locally Advanced Nasopharyngeal Carcinoma Undergoing Concurrent Chemoradiotherapy

Assess body weight at the end of radiotherapy (the weight at the end of radiotherapy - the weight at the beginning of radiotherapy) / the weight at the beginning of radiotherapy \*100 %.

The changes of weight at the last day of radiotherapy

The changes of weight at the end of 4th week

PG-SGA at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy

Incidence of radiation induced grade 3-4 mucositis at the end of 4th week and the last day of radiotherapy

Incidence of any grade 3-4 side-effect induced by radiotherapy or chemotherapy during chemoradiotherapy

Incidence of prolonged radiation treatment time caused by chemoradiation related side-effects. Prolonged radiation treatment time is defined as the overall treatment time is longer than plan

Days prolonged more than planed treatment time caused by chemoradiation related side-effects

Incidence of unplanned hospitalization in 3 months after radiation. Unplanned hospitalization is defined as hospitalization caused by chemoradiotherapy related side effects

The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

PN should be started if enteral nutrition (EN) is anticipated (60% of estimated energy expenditure) for more than 10 days. The treatment time of PN should be recorded

The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H\&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation

Guangdong Provincial People's Hospital

Prof.

Oropharyngeal Neoplasms

Oral supplements are given through oral route 2 weeks before radiotherapy.

Oral supplements are given through oral route on demand during radiotherapy.

Oral supplements are given by tube feeding 2 weeks before radiotherapy.

Oral supplements are given by tube feeding on demand during radiotherapy.

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.

Early nutritional intervention

Guopei Zhu

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).

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.

Cohort 1: nutritional supplements are given through oral route Cohort 2: nutritional supplements are given by tube feeding

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

changes of body weight from baseline to Final Visit/Exit.

Changes of body weight from baseline to V2, V3 and V4

Body Mass Index variables at baseline to V2, V3,V4 and Final Visit/Exit

Calf circumference variables at baseline to V3 and Final Visit/Exit

Lean mass variables at baseline, V3 and Final Visit/Exit

Fat mass variables at baseline, V3 and Final Visit/Exit

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

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 variables at baseline, V3 and Final Visit/Exit

Albumin variables at baseline, V3 and Final Visit/Exit

Hemoglobin variables at baseline, V3 and Final Visit/Exit

White blood cell variables at baseline, V3 and Final Visit/Exit

Peripheral blood lymphocyte variables at baseline, V3 and Final Visit/Exit

Treatment status (e.g., treatment course and doses completed as planned or changed) since last visit at V3, V4 and Final Visit/Exit

Number of days when treatment is suspended due to side effects since last visit at V3, V4 and Final Visit/Exit

Incidence of radio(chemo)therapy-related complications such as oral mucositis, pneumonia, and shingles since last visit at V3, V4 and Final Visit/Exit

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)

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

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

Costs for medications treated for radio(chemo)therapy-related complications during this study

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer	NCT03673657	Local Advanced ...	Early Nutrition... Thoracic radiot... Weekly DP chemo...	18 Years - 75 Years	Sun Yat-sen University
Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy	NCT04810936	Malnutrition Nasopharyngeal ...	oral nutritiona...	18 Years - 74 Years	Guangdong Provincial People's Hospital
Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical	NCT03545490	Malnutrition	Early nutrition...	18 Years - 70 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy	NCT04810936	Malnutrition Nasopharyngeal ...	oral nutritiona...	18 Years - 74 Years	Guangdong Provincial People's Hospital

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