Esophageal NeoplasmsNCT05800054
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer
A study testing Nutritional Support Team, Docetaxel and cisplatin in people with Esophageal Neoplasms and Adverse Drug Event, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Neoplasms, Adverse Drug Event
- What is being tested?
- Nutritional Support Team, Docetaxel and cisplatin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Xiaolin Ge, PhD, 13951818797, doctorsxl@163.com
About this study
Official title: Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy
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.
Read more
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.
- Experimental group: NST whole-course intervention
- 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.
- Radiotherapy
- 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:
- Body weight and body mass index (BMI)
- Quality of life score (EORTCQLQ-C30)
- Nutritional status
- 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
Read the 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.
- Experimental group: NST whole-course intervention
- 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.
- 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.
- 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.
- Control group: routine nutrition guidance for esophageal cancer
- Nutritional therapy: The nutritional program was the same as that of the experimental group, and the patients performed it themselves.
- Concurrent chemoradiotherapy: the same as the experimental group.
Efficacy evaluation:
- Body weight and body mass index (BMI)
- Quality of life score (EORTCQLQ-C30)
- Nutritional status
- 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.
- Conditions
- Esophageal Neoplasms, Adverse Drug Event
- Medical subject headings
- Esophageal Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Support TeamDietary supplement
Also called taixinsheng
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.
DocetaxelDrug
Also called chemotherapy
60-75 mg/m2, d1, at least 2 cycles in parallel with radiotherapy
cisplatinDrug
Also called chemotherapy
cisplatin 25mg/m2 d1-3, 21-28d/cycle. at least 2 cycles in parallel with radiotherapy
RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| NST intervenes throughout the process | Experimental | 1. Nutritionists formulate nutritional programs and manage them in a refined manner.
The nutritionist urges the patient to report daily to ensure that the patient's energy and protein are in place
2. Radiotherapy
3. chemotherapy Receives: Dietary Supplement: Nutritional Support Team; Drug: Docetaxel; Drug: cisplatin; Radiation: Radiotherapy |
| Routine nutrition guidance group for esophageal cancer | Experimental | 1. Patients perform their own nutrition regimen, and the nutritionist is not involved in management
2. Radiotherapy
3. chemotherapy Receives: Drug: Docetaxel; Drug: cisplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight and body mass index (BMI)
BMI = weight ÷ height2. (Unit of weight: kg; Height unit: meters),During treatment: Body weight was recorded daily and BMI was recorded weekly,BMI values are recorded every Friday
Measured: up to 3 years
Secondary outcomes (4)
Quality of life score
EORTCQLQ-C30，EORTC:The European O-rganization for Reasearch and Treatment of Cancer)，QOL-C30 (Quality of Life Questionnare-Core 30，Assessments are conducted every two weeks on Fridays of the second week
Measured: up to 3 years
hemoglobin
Compare the numerical changes of hemoglobin every two weeks
Measured: up to 3 years
serum albumin
Compare the numerical changes of serum albumin every two weeks
Measured: up to 3 years
ORR
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Measured: through study completion, an average of 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800054
- Sponsor's protocol ID
- GXL-001
- Status last verified
- Mar 2023
- First submitted
- 14 Aug 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05800054
- Acronym / sponsor ID
- GXL-001
- Conditions
- Esophageal Neoplasms, Adverse Drug Event
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Experimental group: NST whole-course intervention
- 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.
- Radiotherapy
- 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:
- Body weight and body mass index (BMI)
- Quality of life score (EORTCQLQ-C30)
- Nutritional status
- 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.
- Experimental group: NST whole-course intervention
- 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.
- 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.
- 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.
- Control group: routine nutrition guidance for esophageal cancer
- Nutritional therapy: The nutritional program was the same as that of the experimental group, and the patients performed it themselves.
- Concurrent chemoradiotherapy: the same as the experimental group.
Efficacy evaluation:
- Body weight and body mass index (BMI)
- Quality of life score (EORTCQLQ-C30)
- Nutritional status
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NST intervenes throughout the process | Experimental | Dietary Supplement: Nutritional Support Team, Drug: Docetaxel, Drug: cisplatin, Radiation: Radiotherapy1. Nutritionists formulate nutritional programs and manage them in a refined manner. The nutritionist urges the patient to report daily to ensure that the patient's energy and protein are in place 2. Radiotherapy 3. chemotherapy |
| Routine nutrition guidance group for esophageal cancer | Experimental | Drug: Docetaxel, Drug: cisplatin, Radiation: Radiotherapy1. Patients perform their own nutrition regimen, and the nutritionist is not involved in management 2. Radiotherapy 3. chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Support TeamAlso: taixinshengNutritionists 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. | Dietary supplement | NST intervenes throughout the process |
| DocetaxelAlso: chemotherapy60-75 mg/m2, d1, at least 2 cycles in parallel with radiotherapy | Drug | NST intervenes throughout the process, Routine nutrition guidance group for esophageal cancer |
| cisplatinAlso: chemotherapycisplatin 25mg/m2 d1-3, 21-28d/cycle. at least 2 cycles in parallel with radiotherapy | Drug | NST intervenes throughout the process, Routine nutrition guidance group for esophageal cancer |
| Radiotherapyimage-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. | Radiation | NST intervenes throughout the process, Routine nutrition guidance group for esophageal cancer |
Primary outcome
Body weight and body mass index (BMI)
Time frame: up to 3 years
BMI = weight ÷ height2. (Unit of weight: kg; Height unit: meters),During treatment: Body weight was recorded daily and BMI was recorded weekly,BMI values are recorded every Friday
4 secondary outcomes
Quality of life score
Time frame: up to 3 years
hemoglobin
Time frame: up to 3 years
serum albumin
Time frame: up to 3 years
ORR
Time frame: through study completion, an average of 36 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Support Team, Docetaxel and cisplatin in people with Esophageal Neoplasms and Adverse Drug Event, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolin Ge, PhD (13951818797, doctorsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight and body mass index (BMI) (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.