Nutritional Intervention for Patients With Multiple Cancer Types

Study Overview
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Brief Summary
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To evaluate the nutritional status of patients with different types of tumors by continuous nutritional intervention and follow-up intervention in the perioperative period,and the impact on progression-free survival/survival and quality of life.

Official Title
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An Open, Real-world Study of the Effects of Perioperative Intensive Nutritional Management on Short-term Quality of Life and Long-term Life Outcomes in Patients With Multiple Cancers

Conditions
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Cancer

Intervention / Treatment
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* Dietary Supplement: Nutritional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ① Age ≥18 years old, <80 years old, male or female; ② The patient signed the informed consent and volunteered to participate in the study; ③ Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer) evaluated by clinical stage II to IV; ④ Patients undergoing tumor surgery; ⑤ Patients with NRS 2002 score ≥ 3 after management risk screening; ⑥ Basic reading and communication skills; ⑦ Have the ability to act; Patients with a life expectancy greater than 6 months; Exclusion Criteria: ① Acute onset of chronic disease; ② Pregnant or lactating women; ③ Patients with contraindications and no tumor surgery; (4) Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, stomach cancer, colorectal cancer, liver cancer, pancreatic cancer) were confirmed by pathology and/or cytology after surgery; ⑤ Combined with cognitive dysfunction, mental disorder, consciousness disorder or unwillingness to cooperate; ⑥ Patients with severe gastrointestinal symptoms, liver and renal insufficiency (alanine aminotransferase ALT≥2 times the upper limit of normal value; Total bilirubin Tbil≥2 times the upper limit of normal value; Creatinine Cr≥2 times the upper limit of normal value); (7) Patients with two or more types of tumors; Long-term bed rest, hemiplegia or coma; ⑨ Severe dysfunction of liver, kidney and other organs; ⑩ Allergy or intolerance to nutrients or their main components (such as lactose or galactose, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventian group<br>Intensive nutritional interventions based on real-world treatments | Dietary Supplement: Nutritional therapy<br>* Intensive nutritional therapy based on real world therapy<br>|
| Experimental: control group<br>Nutritional guidance and education based on real world treatments | Dietary Supplement: Nutritional therapy<br>* Intensive nutritional therapy based on real world therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival index | DFS/OS | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life index | Perioperative survival index of patients with multiple cancer types | 3years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, prognosis