Nutritional Risk Screening Nutritional Support Gastrointestinal Cancer

NCT06018246 | Completed

• 1 other identifier: 2022HLL003
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline and through study completion, an average of 1 year

Secondary Outcomes (11)

• Dietary energy intake

  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

  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

  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

  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

  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

Other Outcomes (1)

• Adverse reaction

  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

Study Arms (2)

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.

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.

Other: Conventional nutritional intervention

Interventions

Malnutrition five-step treatment model + conventional nutritional intervention DIETARY_SUPPLEMENT

1. 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.

Intervention Group

Conventional nutritional intervention 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Shanxi Medical University: lead

Study Sites (1)

Huang He

Taiyuan, Shanxi, 045300, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• He Huang, doctor's degree

  The First Affiliated Hospital of Shanxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of gastrointestinal surgery and Section chief of Medical Services Division

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 30, 2023
• Study Start: July 20, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)