Trial Title:
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer
NCT ID:
NCT05800054
Condition:
Esophageal Neoplasms
Adverse Drug Event
Conditions: Official terms:
Esophageal Neoplasms
Drug-Related Side Effects and Adverse Reactions
Docetaxel
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Nutritional Support Team
Description:
Nutritionists formulate nutritional programs and manage them in a refined manner. On the
basis of the patient's natural diet (food and homogenate meal), enteral nutritional
preparations or parenteral nutritional supplements are given according to the patient's
gastrointestinal obstruction, dietary structure, and food intake. Energy 30-35kcal/kg/d,
protein 1.2-1.5g/kg/d. Enteral nutrition administration route: oral or tube feeding or
ostomy, oral feeding is preferred; severe obstruction of eating or oral intake cannot
meet the target nutrition, choose tube feeding or ostomy. When it is expected that
enteral nutrition cannot meet 60% of the target energy requirement for 3 to 5 days,
choose parenteral nutrition. The enteral nutritional preparation adopts the whole protein
enteral nutritional preparation Nengquan, and/or the tumor nutritional preparation
Ruineng, and/or whey protein powder.
Arm group label:
NST intervenes throughout the process
Other name:
taixinsheng
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
60-75 mg/m2, d1, at least 2 cycles in parallel with radiotherapy
Arm group label:
NST intervenes throughout the process
Arm group label:
Routine nutrition guidance group for esophageal cancer
Other name:
chemotherapy
Intervention type:
Drug
Intervention name:
cisplatin
Description:
cisplatin 25mg/m2 d1-3, 21-28d/cycle. at least 2 cycles in parallel with radiotherapy
Arm group label:
NST intervenes throughout the process
Arm group label:
Routine nutrition guidance group for esophageal cancer
Other name:
chemotherapy
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
image-guided intensity-modulated radiotherapy (IGRT) or intensity-modulated radiotherapy
(IMRT); Irradiation targets include primary lesions, clinical targets, positive lymph
nodes, and lymph node drainage areas. Dose splitting/prescription dose, 95% volume
PGTV-T60-66Gy/30-35 times, PGTV-N 60-66Gy/30-35 times, PCTV-T 46-50Gy/23-25 times,
PCTV-N46-50Gy/23-25 times.
Arm group label:
NST intervenes throughout the process
Arm group label:
Routine nutrition guidance group for esophageal cancer
Summary:
This study is a randomized, open, parallel controlled clinical trial. The main purpose of
this study was to compare the changes in body weight/body mass index (BMI) before and
after treatment between the two groups of patients with NST full-course nutritional
management and without NST full-course nutritional management.
The secondary objective was to compare the quality of life, nutritional status, immune
function and inflammatory response, adverse reactions of radiotherapy and chemotherapy,
and short-term/long-term efficacy between the two groups.
The treatment plan was: esophageal cancer with routine nutrition guidance as the control
group, and the NST whole-process intervention guidance as the experimental group.
1. Experimental group: NST whole-course intervention
1. Nutritionists formulate nutritional programs and manage them in a refined manner. On
the basis of the patient's natural diet (food and homogenate meal), enteral
nutritional preparations or parenteral nutritional supplements are given according
to the patient's gastrointestinal obstruction, dietary structure, and food intake.
Energy 30-35kcal/kg/d, protein 1.2-1.5g/kg/d. Enteral nutrition administration
route: oral or tube feeding or ostomy, oral feeding is preferred; severe obstruction
of eating or oral can not meet the target nutrition, choose tube feeding or ostomy.
When it is expected that enteral nutrition cannot meet 60% of the target energy
requirement for 3 to 5 days, choose parenteral nutrition. The enteral nutritional
preparation adopts the whole protein enteral nutritional preparation Nengquan,
and/or the tumor nutritional preparation Ruineng, and/or whey protein powder.
2. Radiotherapy
3. Chemotherapy 2. Control group: routine nutrition guidance for esophageal cancer
(1) Nutritional therapy: The nutritional program was the same as that of the experimental
group, and the patients performed it themselves.
(2) Concurrent chemoradiotherapy: the same as the experimental group.
Efficacy evaluation:
1. Body weight and body mass index (BMI)
2. Quality of life score (EORTCQLQ-C30)
3. Nutritional status
4. Immune function and inflammatory response (total lymphocytes, CRP, IL-6)
(4) Intestinal mucosal barrier and intestinal flora (5) Adverse reactions of radiotherapy
and chemotherapy (6) Short-term/long-term efficacy (5) Evaluation of treatment side
effects (6) Short-term/long-term efficacy
Detailed description:
This study is a randomized, open, parallel controlled clinical trial. The main purpose of
this study was to compare the changes in body weight/body mass index (BMI) before and
after treatment between the two groups of patients with NST full-course nutritional
management and without NST full-course nutritional management.
The secondary objective was to compare the quality of life, nutritional status, immune
function and inflammatory response, adverse reactions of radiotherapy and chemotherapy,
and short-term/long-term efficacy between the two groups.
The treatment plan was: esophageal cancer with routine nutrition guidance as the control
group, and the NST whole-process intervention guidance as the experimental group.
1. Experimental group: NST whole-course intervention
1. Nutritionists formulate nutritional programs and manage them in a refined manner. On
the basis of the patient's natural diet (food and homogenate meal), enteral
nutritional preparations or parenteral nutritional supplements are given according
to the patient's gastrointestinal obstruction, dietary structure, and food intake.
Energy 30-35kcal/kg/d, protein 1.2-1.5g/kg/d. Enteral nutrition administration
route: oral or tube feeding or ostomy, oral feeding is preferred; severe obstruction
of eating or oral can not meet the target nutrition, choose tube feeding or ostomy.
When it is expected that enteral nutrition cannot meet 60% of the target energy
requirement for 3 to 5 days, choose parenteral nutrition. The enteral nutritional
preparation adopts the whole protein enteral nutritional preparation Nengquan,
and/or the tumor nutritional preparation Ruineng, and/or whey protein powder.
Enteral nutrition preparations should choose Nengquan, and the dose of Nengjian: (a)
No/mild obstruction, can eat ordinary diet, the food intake is not reduced or less
than 1/3 before the disease, and 10-15kcal of Nengjian is given. /kg/d; (b) moderate
obstruction, can eat soft food, the food intake is less than 1/3~2/3 before the
disease, and can give 15-20kcal/kg/d; (c) severe obstruction, can not Eating, the
food intake is reduced by >= 2/3 compared with that before the disease, and can be
given 20-25kcal/kg/d of all-vegetarian food; Dosage of whey protein powder: (a)
albumin 35~40g/L, supplemented with whey protein powder 10g; (b) albumin 30~35g/L,
supplemented with whey protein powder 20g; (c) albumin <30g /L, supplement whey
protein powder 30g.
Nutritionists urge patients to report daily to ensure adequate energy and protein
supplementation.
2. Radiotherapy: image-guided intensity-modulated radiotherapy (IGRT) or
intensity-modulated radiotherapy (IMRT); the irradiation target areas include
primary lesions, clinical target areas, positive lymph nodes, and lymph node
drainage areas. Dose split/prescribed dose, 95% volume PGTV-T60-66Gy/30-35 times,
PGTV-N 60-66Gy/30-35 times, PCTV-T 46-50Gy/23-25 times, PCTV-N46-50Gy/ 23-25 times.
3. Chemotherapy: Docetaxel 60-75mg/m2, d1, DDP 25mg/m2 d1-3, 21-28d/cycle. Simultaneous
with radiotherapy for at least 2 cycles, after radiotherapy, the choice of whether
to continue adjuvant chemotherapy is based on specific circumstances.
2. Control group: routine nutrition guidance for esophageal cancer
1. Nutritional therapy: The nutritional program was the same as that of the
experimental group, and the patients performed it themselves.
2. Concurrent chemoradiotherapy: the same as the experimental group.
Efficacy evaluation:
1. Body weight and body mass index (BMI)
2. Quality of life score (EORTCQLQ-C30)
3. Nutritional status
4. Immune function and inflammatory response (total lymphocytes, CRP, IL-6)
(4) Intestinal mucosal barrier and intestinal flora (5) Adverse reactions of radiotherapy
and chemotherapy (6) Short-term/long-term efficacy (5) Evaluation of treatment side
effects (6) Short-term/long-term efficacy Statistical methods: All statistical tests were
two-sided, and P values < 0.05 were considered statistically significant. Data are
presented as x ±s. Quantitative data were analyzed by t test and variance analysis,
qualitative data were analyzed by X2 test, and survival data were analyzed by Kaplan
Meire method, logrank test, and Cox regression.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Sign the informed consent; must have good compliance with the treatment plan and
follow-up.
- No gender restriction, but age between 18 and 75 years old;
- Cytological or histological is confirmed esophageal squamous cell carcinoma;
- Non-surgical treatment of stage II-III primary esophageal cancer (except biopsy);
- The primary tumor can be evaluated;
- No distant organ metastasis;
- PG-SGA score B (2~8) or C (≥9);
- KPS score ≥ 70 points, ECOG physical condition score 0-1 points;
- The function of major organs (bone marrow, liver, kidney function) 7 days before
treatment, meet the following criteria: Blood routine examination standards (without
blood transfusion within 14 days):
- Hemoglobin (HB) ≥ 100g/L;
- White blood cells (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC)
≥1.5×109/L;
- Platelet (PLT) ≥ 100×109/L.
- The biochemical examination shall meet the following standards:
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 1.5
times ULN;
- Serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance rate
(CCr) ≥ 60ml/min.
- Expected survival ≥ 6 months.
Exclusion Criteria:
- No malnutrition or nutritional risk; PG-SGA score of A;
- Severely impaired intestinal function, or intolerance of enteral nutrition;
- Severe vomiting, gastrointestinal bleeding, intestinal obstruction;
- Patients with very severe malnutrition cannot tolerate radiotherapy and
chemotherapy;
- The primary tumor or lymph node has received radiotherapy, chemotherapy or targeted
therapy;
- Suffering from other malignant tumors within 5 years (except for completely cured
cervical carcinoma in situ or skin basal cell carcinoma);
- Subjects who have received other drug trials within the past month;
- Those with severe allergic history or idiosyncratic constitution;
- Those with a history of severe lung or heart disease;
- Serious comorbidities, such as uncontrolled hypertension, heart failure, etc.;
- Pregnant or breastfeeding women;
- Currently or planning to participate in other clinical trials;
- Refusal or inability to sign the informed consent form to accept participation in
the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolin Ge, PhD
Phone:
13951818797
Email:
doctorsxl@163.com
Start date:
January 1, 2021
Completion date:
December 31, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05800054
