Nutrition-support-team Based Intervention in Patients With Advanced Gastrointestinal Cancer

Study Overview
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Brief Summary
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The research studies patients with advanced gastrointestinal cancer who receive chemotherapy in the medical oncology department of the First Affiliated Hospital of Xian Jiaotong University. All patients receive the nutritional risk assessment by the nutritional support team first, and patients with nutritional risk or malnutrition are randomly assigned to the study group and the control group. The study group receive nutritional intervention from the nutritional support team during the period of chemotherapy, while the control group receive routine nutritional support from their clinicians. In the control group, nurses execute the doctors' advice on nutrition, and the nutrition support team does not actively communicate with doctors about the nutritional risk of patients or interfere with it. The baseline characteristics, chemotherapy efficacy, adverse events and prognosis are collected in both groups. At last, data are analyzed to clarify the nutritional status and related factors of patients with advanced gastrointestinal cancer in our hospital, and most important to explore the effect of nutrition-support-team intervention on nutritional status, chemotherapy tolerance and prognosis of patients with advanced gastrointestinal cancer.

Detailed Description
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Baseline data include age, gender, pain, sleep condition, family care, tumor type, tumor stage, combined disease, chemotherapy regimen and concomitant medication. Nutritional risk assessments are performed by the nutrition support team just after enrollment, every two cycles of chemotherapy and at the end of the study. The adverse events of chemotherapy are collected and recorded at the end of each cycle. CT or MRI is performed to evaluate efficacy of chemotherapy every two treatment cycles. Patient after one treatment cycle can receive CT or MRI in advance if the clinical condition is worsening.

Official Title
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Effect of Nutrition-support-team Based Intervention on Nutritional Status, Chemotherapy Tolerance and Prognosis in Patients With Advanced Gastrointestinal Cancer

Conditions
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Malnutrition, Gastrointestinal Cancer, Nutrition Aspect of Cancer

Intervention / Treatment
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* Other: NST group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: advanced (recurrent or metastatic) gastrointestinal malignancies confirmed by pathology, plan to be treated with chemotherapy the expected life period is more than 3 months did not receive chemotherapy, radiotherapy, molecular targeted therapy or surgery in the last 4 weeks has been recovered from the acute toxicity of previous treatment (if patient received surgery, the wound must have completely healed) at least one measurable lesion according to RECIST 1.1 edition (the measurable lesion has not received radiotherapy) normal function of main organs:Blood routine examination needs to be met: Hb≥90g/L (without blood transfusions within 14 days); ANC≥1.5×109/L; PLT≥80×109/LBiochemical examination should conform to the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN (ALT and AST≤5×ULN, in case of liver metastasis); Serum creatinine ≤1×ULN, creatinine clearance rate >50ml/min (Cockcroft-Gault formula) volunteer to participate in the study, sign the informed consent, and cooperate with good compliance Exclusion Criteria: pregnancy or lactation having a long-term unhealed wound, traumatic or pathological fracture urinary protein > 2+ or 24 hour urinary protein >1.0g suffering from mental illness with hypertension and fail to get good control through antihypertensive medication (systolic pressure >140mmHg and/or diastolic pressure >90mmHg) serious diabetes, heart disease (including but not limited to myocardial ischemia, myocardial infarction, cardiac insufficiency, congestive heart failure), thrombotic diseases (including but not limited to cerebral hemorrhage, deep venous thrombosis and pulmonary embolism) long-term use of steroid for other medical reasons with diseases that may increasing the underlying research risk judged by researchers having a bleeding tendency or a great worry of gastrointestinal bleeding with infection requiring antibiotic treatment history of immunodeficiency, including HIV positive, organ transplantation and other acquired/congenital immunodeficiency disorders patients with Hepatitis B(except inactive carrier) or Hepatitis C took part in other clinical studies or is involved in other research projects at present

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study group: receive nutritional intervention from the nutritional support team; Control group: receive routine nutritional support from clinicians
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NST group<br>Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy | Other: NST group<br>* Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education<br>|
| No Intervention: routine group<br>clinicians decide whether to give and how to give the dietary supplement and other nutritional support | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional status | effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments | From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemo-related adverse events | amount of chemo-related adverse events | From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months | 
| total chemotherapy cycles | amount of total cycles of chemotherapy | From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months | 
| progression-free survival | the survival time of patient without progression | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months | 
| adverse events | Amount of adverse events related to nutritional intervention | From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months |