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

Primary Purpose

Malnutrition, Gastrointestinal Cancer, Nutrition Aspect of Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NST group
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NST group

routine group

Arm Description

Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy

clinicians decide whether to give and how to give the dietary supplement and other nutritional support

Outcomes

Primary Outcome Measures

nutritional status
effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments

Secondary Outcome Measures

chemo-related adverse events
amount of chemo-related adverse events
total chemotherapy cycles
amount of total cycles of chemotherapy
progression-free survival
the survival time of patient without progression
adverse events
Amount of adverse events related to nutritional intervention

Full Information

First Posted
August 13, 2018
Last Updated
August 19, 2018
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03631537
Brief Title
Nutrition-support-team Based Intervention in Patients With Advanced Gastrointestinal Cancer
Acronym
NSTBIPAGC
Official Title
Effect of Nutrition-support-team Based Intervention on Nutritional Status, Chemotherapy Tolerance and Prognosis in Patients With Advanced Gastrointestinal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Anticipated)
Primary Completion Date
August 20, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Gastrointestinal Cancer, Nutrition Aspect of Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study group: receive nutritional intervention from the nutritional support team; Control group: receive routine nutritional support from clinicians
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NST group
Arm Type
Experimental
Arm Description
Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy
Arm Title
routine group
Arm Type
No Intervention
Arm Description
clinicians decide whether to give and how to give the dietary supplement and other nutritional support
Intervention Type
Other
Intervention Name(s)
NST group
Intervention Description
Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education
Primary Outcome Measure Information:
Title
nutritional status
Description
effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments
Time Frame
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 Measure Information:
Title
chemo-related adverse events
Description
amount of chemo-related adverse events
Time Frame
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
Title
total chemotherapy cycles
Description
amount of total cycles of chemotherapy
Time Frame
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
Title
progression-free survival
Description
the survival time of patient without progression
Time Frame
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
Title
adverse events
Description
Amount of adverse events related to nutritional intervention
Time Frame
From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingxiao Zhang, doctor
Phone
+8618066910386
Email
514324869@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lingxiao Zhang, doctor
Organizational Affiliation
First Affiliated Hospital of Xian Jiaotong University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingxiao Zhang, doctor
Phone
+8618066910386
Email
514324869@qq.com

12. IPD Sharing Statement

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

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