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Clinical Study on Nutrition Intervention in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy

Primary Purpose

Nutrition Aspect of Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional counseling,Enteral Nutrition
Sponsored by
Hunan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Aspect of Cancer

Eligibility Criteria

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

Inclusion Criteria: Esophageal or gastric cancer confirmed by histology or cytology; Age 18-75 years old, gender unlimited; Blood routine: hemoglobin ≥90g/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L; (2) Liver and kidney function: alanine transaminase(ALT), glutamic-oxalacetic transaminease(AST)≤2.5 times the normal upper limit (with liver metastasis ≤5 times the normal upper limit); ALP≤2.5 times the normal upper limit (≤5 times the normal upper limit for patients with liver or bone metastasis); Serum total bilirubin (TBIL) was less than 1.5 times the normal upper limit. Serum creatinine (SCr) < 1.5 times the upper limit of normal; ③ Blood biochemistry: Serum albumin (ALB) ≥30g/L; Predicted survival of more than 3 months; It is planned to continue chemotherapy for >3 cycles in the hospital or outpatient department All patients participated in this study voluntarily and signed informed consent. Exclusion Criteria: Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors; Have serious heart, lung and brain diseases; Complicated with chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, etc. Fever associated with infection; Have difficult-to-control diabetes or other metabolic diseases; Patients with unstable vital signs and multiple organ failure; The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires. The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable for participating in this clinical study for other reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Nutritional Counseling

    Nutrition Support Therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Nutritional risk screening(NRS) 2002 scale
    Nutritional risk screening(NRS) 2002 scale of patients with esophageal and gastric cancer before and after chemotherapy. The score includes 0,1,2,3,4,5,6 and 7.

    Secondary Outcome Measures

    rates of malnutrition of patients
    Rates of malnutrition of patients with esophageal and gastric cancer before and after chemotherapy. The result is shown as "percent".
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D (score of 0-1)
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D VAS (score of 1-100)

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Hunan Cancer Hospital
    Collaborators
    The Third Xiangya Hospital of Central South University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06022770
    Brief Title
    Clinical Study on Nutrition Intervention in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy
    Official Title
    Clinical Study on Nutrition Intervention to Improve Nutrition and Quality of Life in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hunan Cancer Hospital
    Collaborators
    The Third Xiangya Hospital of Central South University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as research objects to conduct nutritional risk screening, malnutrition assessment and quality of life assessment. They were randomized into the nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients with esophageal cancer and gastric cancer before and after chemotherapy, and to study the effects of nutritional support therapy on nutrition and life quality.
    Detailed Description
    In view of the high incidence of malnutrition in esophageal cancer and gastric cancer and chemotherapy may further aggravate malnutrition and reduce quality of life. According to the inclusion criteria, 280 patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as research objects to conduct nutritional risk screening, malnutrition assessment and quality of life assessment. They were randomized into the nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients with esophageal cancer and gastric cancer before and after chemotherapy, and to study the effects of nutritional support therapy on nutrition and life quality; On this basis, a nutrition and life quality management system for patients with tubular upper digestive tract chemotherapy tumors was constructed, and the system was objectively evaluated from the clinical point of view, so as to provide a feasible scheme for improving the nutrition and life quality of patients with tubular upper digestive tract chemotherapy tumors.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutritional Counseling
    Arm Type
    No Intervention
    Arm Title
    Nutrition Support Therapy
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutritional counseling,Enteral Nutrition
    Intervention Description
    patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as the study objects for nutritional risk screening, malnutrition assessment and quality of life assessment. Randomly enter the nutrition consultation group (NC) and nutrition support treatment group (NST)
    Primary Outcome Measure Information:
    Title
    Nutritional risk screening(NRS) 2002 scale
    Description
    Nutritional risk screening(NRS) 2002 scale of patients with esophageal and gastric cancer before and after chemotherapy. The score includes 0,1,2,3,4,5,6 and 7.
    Time Frame
    Nutritional risk screening(NRS) 2002 scale during day 1 and day 42
    Secondary Outcome Measure Information:
    Title
    rates of malnutrition of patients
    Description
    Rates of malnutrition of patients with esophageal and gastric cancer before and after chemotherapy. The result is shown as "percent".
    Time Frame
    rates of malnutrition of patients during day 1 and day 42
    Title
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy
    Description
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D (score of 0-1)
    Time Frame
    rates of quality of life of patients during day 1 and day 42
    Title
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy
    Description
    quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D VAS (score of 1-100)
    Time Frame
    rates of quality of life of patients during day 1 and day 42

    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: Esophageal or gastric cancer confirmed by histology or cytology; Age 18-75 years old, gender unlimited; Blood routine: hemoglobin ≥90g/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L; (2) Liver and kidney function: alanine transaminase(ALT), glutamic-oxalacetic transaminease(AST)≤2.5 times the normal upper limit (with liver metastasis ≤5 times the normal upper limit); ALP≤2.5 times the normal upper limit (≤5 times the normal upper limit for patients with liver or bone metastasis); Serum total bilirubin (TBIL) was less than 1.5 times the normal upper limit. Serum creatinine (SCr) < 1.5 times the upper limit of normal; ③ Blood biochemistry: Serum albumin (ALB) ≥30g/L; Predicted survival of more than 3 months; It is planned to continue chemotherapy for >3 cycles in the hospital or outpatient department All patients participated in this study voluntarily and signed informed consent. Exclusion Criteria: Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors; Have serious heart, lung and brain diseases; Complicated with chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, etc. Fever associated with infection; Have difficult-to-control diabetes or other metabolic diseases; Patients with unstable vital signs and multiple organ failure; The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires. The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable for participating in this clinical study for other reasons

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Clinical Study on Nutrition Intervention in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy

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