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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NST group | Experimental | Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy |
|
| routine group | No Intervention | clinicians decide whether to give and how to give the dietary supplement and other nutritional support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NST group | Other | Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingxiao Zhang, doctor | Contact | +8618066910386 | 514324869@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Lingxiao Zhang, doctor | First Affiliated Hospital of Xian Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Study group: receive nutritional intervention from the nutritional support team; Control group: receive routine nutritional support from clinicians
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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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |