Gastrointestinal CancerNCT06018246
Nutritional Risk Screening Nutritional Support Gastrointestinal Cancer
A study testing Malnutrition five-step treatment model + conventional nutritional intervention and Conventional nutritional intervention in people with Gastrointestinal Cancer, run by The First Affiliated Hospital of Shanxi Medical University at 1 site in China.
Trial summary
The goal of this clinical trial was to compare the effects of different nutritional support methods based on nutritional risk screening on postoperative nutritional status in patients with gastrointestinal tumors.The main question it aims to answer is that different types of nutrition can improve the nutritional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Malnutrition five-step treatment model + conventional nutritional intervention and Conventional nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years；
- The first pathological diagnosis was gastric or colorectal cancer and radical resection of malignant tumor was performed；
- Conscious, able to read, write and understand the study；
- Sign informed consent and participate in this study voluntarily.
Who cannot join
- Patients with malignant tumors at other sites；
- Patients undergoing neoadjuvant chemotherapy before surgery；
- Anastomotic fistula, anastomotic obstruction, gastroparesis and other serious complications occurred after operation；
- There are mental disorders, psychological disorders；
- Patients who did not cooperate to complete the full intervention or follow-up records were missing；
- Patients with missing baseline data and nutritional risk screening results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Nutritional Support Modes Based on Nutritional Risk Screening on Postoperative Nutritional Status of Patients With Gastrointestinal Cancer
The goal of this clinical trial was to compare the effects of different nutritional support methods based on nutritional risk screening on postoperative nutritional status in patients with gastrointestinal tumors.The main question it aims to answer is that different types of nutrition can improve the nutritional status of patients with different nutritional status;Long-term dietary interventions for patients with poor nutrition can make cancer patients better able to tolerate surgery and chemotherapy and improve their quality of life.The intervention group received nutrition + exercise + psychological intervention upon admission, routine parenteral and enteral nutrition support after operation, and continued nutrition + exercise + psychological intervention after discharge.The control group received routine parenteral nutrition support in the department after surgery, and the patients and their families were given diet education during hospitalization.
Read the detailed description
Purpose: The investigators conducted nutritional risk screening for patients with gastrointestinal tumors, gave different nutritional support methods to patients with different nutritional status, and analyzed the changes of various nutritional indexes of patients before and after nutritional intervention.
Methods: A total of 302 patients with gastrointestinal tumors admitted to the First Hospital of Shanxi Medical University from July 2021 to June 2023 were selected.All patients underwent nutritional risk screening after admission and were divided into intervention group (NRS2002≥3 and PG=SGA≥4, n=204) and control group (NRS2002 < 3 or PG=SGA < 4 , n=98) according to the screening results.Different nutritional interventions were given to analyze the changes of NRS-2002 and PG-SGA scores between the two groups before and after propensity score matching, and compare the changes of dietary energy, dietary protein, total energy, total protein, body mass index (BMI), fat-free weight, walking time, grip strength and other nutritional indicators (hemoglobin, albumin, prealbumin) between the two groups.The effects of disease type and age on the results were compared by stratified analysis.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Malnutrition five-step treatment model + conventional nutritional intervention, Conventional nutritional intervention
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malnutrition five-step treatment model + conventional nutritional interventionDietary supplement
- Before operation：Same as arm description.
- After operation:Same as control group.
- Out-of-hospital: Same as before operation.
- Strengthening Health Education and psychological intervention:Dietitians need to strengthen health education and communicate with patients during the implementation of nutrition intervention.For patients who actively cooperate with treatment, dietitians can give encouragement.
- Exercise Instruction:After the operation, according to the tolerance, the dietitian can instruct the patient to take a certain time walking every day, gradually increase the patient's muscle endurance and improve the body resistance.
Conventional nutritional interventionOther
Routine nutrition support in department.Nutritionists will give patients routine parenteral nutrition support via peripheral or central vein 0-48 hours after surgery and then start enteral nutrition support 48-72 hours after surgery.Patients were initially given half of their enteral nutrition and the rest was supplemented with parenteral nutrition.After adaptation, the patient stopped parenteral nutrition and all nutrition came from enteral nutrition.After the patient's gastrointestinal function gradually recovered, the enteral nutrition could gradually decrease.At this time, nutritionists can let the patient eat some light liquid food, but pay attention to eating a small amount of multiple times.After adaptation, patients can gradually transition from liquid diet to semi-liquid diet.We will educate patients and their families about diet and encourage them to eat more high-quality protein-rich foods.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 1. Before operation：The patients' dietary intake was assessed by a 24-hour dietary review by a professional dietitian.According to the diet of the patients, the intervention was carried out by a professional nutritionist according to the five-step treatment mode of malnutrition.If the food intake cannot meet 60% of the daily requirement, the previous step of treatment is used, and it is adjusted at any time according to the situation of the patient.
2. After operation:Same as control group.
3. Out-of-hospital: Same as before operation.
4. Strengthening Health Education and psychological intervention:Dietitians need to strengthen health education and communicate with patients during the implementation of nutrition intervention.For patients who actively cooperate with treatment, dietitians can give encouragement.
5. Exercise Instruction:After the operation, according to the tolerance, the dietitian can instruct the patient to take a certain time walking every day. Receives: Dietary Supplement: Malnutrition five-step treatment model + conventional nutritional intervention |
| Control Group | Other | Routine nutrition support in department.Nutritionists will give patients routine parenteral nutrition support via peripheral or central vein 0-48 hours after surgery and then start enteral nutrition support 48-72 hours after surgery.Patients were initially given half of their enteral nutrition and the rest was supplemented with parenteral nutrition.After adaptation, the patient stopped parenteral nutrition and all nutrition came from enteral nutrition.After the patient's gastrointestinal function gradually recovered, the enteral nutrition could gradually decrease.At this time, nutritionists can let the patient eat some light liquid food, but pay attention to eating a small amount of multiple times.After adaptation, patients can gradually transition from liquid diet to semi-liquid diet.We will educate patients and their families about diet and encourage them to eat more high-quality protein-rich foods. Receives: Other: Conventional nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional risk screening 2002
Nutritional risk screening scale：The maximum score of NRS2002 is 7 points and the minimum score is 0 points. A score of NRS2002≥3 indicates the presence of nutritional risk, and nutritional support programs should be developed in combination with clinical practice. A score of NRS2002 < 3 indicates no nutritional risk, and a review is performed 1 week later.
Measured: baseline and through study completion, an average of 1 year
Patient-generated subjective nutrition assessment
Nutritional risk screening scale：0-1 score, no intervention is required at this time, regular regular nutritional status score. 2 to 3 points, the nutritionist, nurse or clinician to educate the patient and family, and appropriate drug intervention for symptoms and laboratory tests. 4-8 points, requiring nutritional intervention and symptomatic treatment. A score of ≥9 indicates an urgent need for symptomatic treatment and appropriate nutrient support.
Measured: baseline and through study completion, an average of 1 year
Secondary outcomes (11)
Dietary energy intake
The 24-hour dietary review method was used to investigate the diet of the patients in the first 24 hours, and all the foods were converted into the energy value of the foods, and the dietary energy intake of the patients was calculated by adding.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Dietary protein intake
The 24-hour dietary review method was used to investigate the diet of the patients in the first 24 hours, and the protein amount provided by each food was recorded, and the dietary protein intake of the patients was calculated by adding.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Nutrient energy intake
The nutritional energy provided by oral nutrition, enteral nutrition and parenteral nutrition was recorded through inquiry and inquiry of nursing records.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Nutrient protein intake
The nutritional proteins provided by oral nutrition, enteral nutrition and parenteral nutrition were recorded through inquiry and inquiry of nursing records.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Prealbumin
Laboratory indicators on nutrition
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Albumin
Laboratory indicators on nutrition
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Hemoglobin
Laboratory indicators on nutrition
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
BMI
Dietitians use a body fat scale to measure a patient's weight.When measuring the patient's weight, the body fat scale should be placed on a horizontal, firm floor.The patient takes off shoes and socks and wears light clothes.The patient then stood on the scale, keeping his body naturally upright.The patient's arms should be naturally drooped and relaxed at the sides of the body.Each weight measurement should be set at the same time.The dietitian uses a height meter to measure the patient's height.Weight and height will be combined to report BMI in kg/m^2.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Fat-free body weight
Dietitians use a body fat scale to measure a patient's fattened weight.When measuring the patient's weight without fat, the body fat scale should be placed on a level, firm floor.The patient takes off shoes and socks and wears light clothes.The patient then stood on the scale, keeping his body naturally upright.The patient's arms should be naturally drooped and relaxed at the sides of the body.The weight loss should be measured at the same time each time.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Grip strength
A dietitian uses a grip dynamometer to measure a patient's grip strength.When grip strength is measured, the patient's hands naturally droop and no other hand movements can be seen.Dietitians advise patients to measure their grip strength as best they can.The patient is tested on both hands, usually three times with each hand, and an average is taken.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Walking time
The patients were asked about their daily walking time.
Measured: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start20 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang He, The First Affiliated Hospital of Shanxi Medical University
- Investigators
- He Huang, doctor's degree, Study director, The First Affiliated Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018246
- Sponsor's protocol ID
- 2022HLL003
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Nutritional Support Modes Based on Nutritional Risk Screening on Postoperative Nutritional Status of Patients With Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT06018246
- Acronym / sponsor ID
- 2022HLL003
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 30 Aug 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.
The goal of this clinical trial was to compare the effects of different nutritional support methods based on nutritional risk screening on postoperative nutritional status in patients with gastrointestinal tumors.The main question it aims to answer is that different types of nutrition can improve the nutritional status of patients with different nutritional status;Long-term dietary interventions for patients with poor nutrition can make cancer patients better able to tolerate surgery and chemotherapy and improve their quality of life.The intervention group received nutrition + exercise + psychological intervention upon admission, routine parenteral and enteral nutrition support after operation, and continued nutrition + exercise + psychological intervention after discharge.The control group received routine parenteral nutrition support in the department after surgery, and the patients and their families were given diet education during hospitalization.
Detailed description
Purpose: The investigators conducted nutritional risk screening for patients with gastrointestinal tumors, gave different nutritional support methods to patients with different nutritional status, and analyzed the changes of various nutritional indexes of patients before and after nutritional intervention.
Methods: A total of 302 patients with gastrointestinal tumors admitted to the First Hospital of Shanxi Medical University from July 2021 to June 2023 were selected.All patients underwent nutritional risk screening after admission and were divided into intervention group (NRS2002≥3 and PG=SGA≥4, n=204) and control group (NRS2002 < 3 or PG=SGA < 4 , n=98) according to the screening results.Different nutritional interventions were given to analyze the changes of NRS-2002 and PG-SGA scores between the two groups before and after propensity score matching, and compare the changes of dietary energy, dietary protein, total energy, total protein, body mass index (BMI), fat-free weight, walking time, grip strength and other nutritional indicators (hemoglobin, albumin, prealbumin) between the two groups.The effects of disease type and age on the results were compared by stratified analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Malnutrition five-step treatment model + conventional nutritional intervention1. Before operation：The patients' dietary intake was assessed by a 24-hour dietary review by a professional dietitian.According to the diet of the patients, the intervention was carried out by a professional nutritionist according to the five-step treatment mode of malnutrition.If the food intake cannot meet 60% of the daily requirement, the previous step of treatment is used, and it is adjusted at any time according to the situation of the patient. 2. After operation:Same as control group. 3. Out-of-hospital: Same as before operation. 4. Strengthening Health Education and psychological intervention:Dietitians need to strengthen health education and communicate with patients during the implementation of nutrition intervention.For patients who actively cooperate with treatment, dietitians can give encouragement. 5. Exercise Instruction:After the operation, according to the tolerance, the dietitian can instruct the patient to take a certain time walking every day. |
| Control Group | Other | Other: Conventional nutritional interventionRoutine nutrition support in department.Nutritionists will give patients routine parenteral nutrition support via peripheral or central vein 0-48 hours after surgery and then start enteral nutrition support 48-72 hours after surgery.Patients were initially given half of their enteral nutrition and the rest was supplemented with parenteral nutrition.After adaptation, the patient stopped parenteral nutrition and all nutrition came from enteral nutrition.After the patient's gastrointestinal function gradually recovered, the enteral nutrition could gradually decrease.At this time, nutritionists can let the patient eat some light liquid food, but pay attention to eating a small amount of multiple times.After adaptation, patients can gradually transition from liquid diet to semi-liquid diet.We will educate patients and their families about diet and encourage them to eat more high-quality protein-rich foods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Malnutrition five-step treatment model + conventional nutritional intervention1. Before operation：Same as arm description. 2. After operation:Same as control group. 3. Out-of-hospital: Same as before operation. 4. Strengthening Health Education and psychological intervention:Dietitians need to strengthen health education and communicate with patients during the implementation of nutrition intervention.For patients who actively cooperate with treatment, dietitians can give encouragement. 5. Exercise Instruction:After the operation, according to the tolerance, the dietitian can instruct the patient to take a certain time walking every day, gradually increase the patient's muscle endurance and improve the body resistance. | Dietary supplement | Intervention Group |
| Conventional nutritional interventionRoutine nutrition support in department.Nutritionists will give patients routine parenteral nutrition support via peripheral or central vein 0-48 hours after surgery and then start enteral nutrition support 48-72 hours after surgery.Patients were initially given half of their enteral nutrition and the rest was supplemented with parenteral nutrition.After adaptation, the patient stopped parenteral nutrition and all nutrition came from enteral nutrition.After the patient's gastrointestinal function gradually recovered, the enteral nutrition could gradually decrease.At this time, nutritionists can let the patient eat some light liquid food, but pay attention to eating a small amount of multiple times.After adaptation, patients can gradually transition from liquid diet to semi-liquid diet.We will educate patients and their families about diet and encourage them to eat more high-quality protein-rich foods. | Other | Control Group |
Primary outcome
Nutritional risk screening 2002
Time frame: baseline and through study completion, an average of 1 year
Nutritional risk screening scale：The maximum score of NRS2002 is 7 points and the minimum score is 0 points. A score of NRS2002≥3 indicates the presence of nutritional risk, and nutritional support programs should be developed in combination with clinical practice. A score of NRS2002 < 3 indicates no nutritional risk, and a review is performed 1 week later.
Patient-generated subjective nutrition assessment
Time frame: baseline and through study completion, an average of 1 year
Nutritional risk screening scale：0-1 score, no intervention is required at this time, regular regular nutritional status score. 2 to 3 points, the nutritionist, nurse or clinician to educate the patient and family, and appropriate drug intervention for symptoms and laboratory tests. 4-8 points, requiring nutritional intervention and symptomatic treatment. A score of ≥9 indicates an urgent need for symptomatic treatment and appropriate nutrient support.
11 secondary outcomes
Dietary energy intake
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Dietary protein intake
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Nutrient energy intake
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Nutrient protein intake
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Prealbumin
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Albumin
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Hemoglobin
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
BMI
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Fat-free body weight
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Grip strength
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Walking time
Time frame: baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 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. This study is not recruiting at the moment.
He Huang, doctor's degree study director
The First Affiliated Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malnutrition five-step treatment model + conventional nutritional intervention and Conventional nutritional intervention in people with Gastrointestinal Cancer, run by The First Affiliated Hospital of Shanxi 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 30 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional risk screening 2002 (time frame: baseline and through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 30 Aug 2023.