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Effect of Exercise and Enteral Nutrition on Survival (ENERGY)

Primary Purpose

Gastric Cancer, Nutrition Related Cancer, Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise Intervention
Nutrition Intervention
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:(1) 18 years ≤ age ≤ 70 years (2) Preoperative Karnofsky physical condition score: 0 or 1 or 2 (3) Preoperative pathological biopsy by gastroscope, histologically confirmed as adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma) (4) Gastric cancer patients diagnosed with clinical stage Ib IIIc through CT, MRI, gastroscopy, and pathology (based on the 8th edition of UICC/AJCC staging) (5) Abdominal enhanced CT/MRI examination showed a clinical staging of cT2-4aN0-3M0 (based on AJCC-8thTNM tumor staging), and standard D2 radical surgery for gastric cancer was performed; (6) Have not received any radiotherapy, chemotherapy or immunotherapy; (7) Hemoglobin ≥ 80g/L; (8) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; (9) Platelets ≥ 75 × 109/L; (10) ALT ≤ 2.5 times the normal upper limit value; (11) AST ≤ 2.5 times the normal upper limit value; (12) ALP ≤ 2.5 times the normal upper limit value; (13) Serum total bilirubin<1.5 times the upper normal limit value; (14) Serum creatinine<1 times the upper normal limit value; (15) Sign written informed consent; Exclusion Criteria: Patients diagnosed with distant metastasis through abdominal lung CT/MRI or PET-CT Pregnant or lactating women People with uncontrolled epilepsy, Central nervous system disease or mental disorders Patients with combined limb disabilities or motor dysfunction; Patients with other malignant diseases in the past five years, excluding cured skin cancer and cervical Carcinoma in situ Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction within the past 6 months Have a history of cerebral infarction or cerebral hemorrhage in the past 6 months Organ transplantation requires immunosuppressive therapy Serious uncontrolled recurrent infections or other serious uncontrolled concomitant diseases The patient has complications of Grade III or above in Clavien Dindo classification or has been hospitalized for more than 14 days after surgery due to various reasons; Urgent surgery required due to tumor emergencies (bleeding, perforation, obstruction) Pulmonary function test FEV1<expected value 50% Received radiotherapy, chemotherapy, or other neoadjuvant treatment before surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Exercise and Enteral Nutrition Intervention

    Enteral Nutrition Intervention

    Arm Description

    A comprehensive postoperative management combined physical exercise intervention with oral nutritional support

    The control group will not receive exercise intervention, but will receive postoperative nutritional support treatment with the same standards as the experimental group.

    Outcomes

    Primary Outcome Measures

    3-year overall survival rate
    The 3-year overall survival rate refers to the proportion of gastric cancer patients who have survived for more than 3 years after various comprehensive treatments

    Secondary Outcome Measures

    3-year disease-free survival rate
    The proportion of clinically confirmed complete remission to recurrence within 3 years
    Scored Patient-Generated Subjective Global Assessment, PG-SGA
    Scored Patient-Generated Subjective Global Assessment is the preferred method recommended by the American Dietitian Association for nutritional screening of tumor patients. It can conduct qualitative and quantitative comprehensive evaluation of patients' nutritional status from four aspects: weight loss, disease and age, metabolic stress status, and physical examination. It is a sensitive evaluation scale for patients to malnutrition changes
    QLQ-C30 assessment
    The quality of life of patients 6 months after surgery was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), which can evaluate the quality of life from a multidimensional perspective and better reflect the connotation of quality of life. It is widely used in clinical practice to measure the quality of life of cancer patients.

    Full Information

    First Posted
    July 17, 2023
    Last Updated
    July 17, 2023
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05959226
    Brief Title
    Effect of Exercise and Enteral Nutrition on Survival
    Acronym
    ENERGY
    Official Title
    Effect of Exercise and Enteral Nutrition Intervention on Survival in Patients With Locally Advanced Gastric Cancer: a Prospective Multicenter Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2026 (Anticipated)
    Study Completion Date
    August 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The present clinical trial was designed to explore the effect of postoperative physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer.
    Detailed Description
    The present clinical trial was designed to explore the effect of physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer. In the trial group, comprehensive postoperative management model with targeted exercise intervention and nutritional support. The details are as follows: Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of enteral nutrition supplement (ONS) in addition to their normal diet. Once the patient's oral diet decreases, ONS will be added several times a day to ensure that the total energy reaches the ESPEN recommended daily 30 kcal/kg. The daily protein requirement is set at 1.2-1.5 g/kg of actual body weight. The Dietitian will keep records and help patients adjust their energy intake weekly. Exercise: under the guidance of the rehabilitation therapist, the patient gradually recovers Exercise from discharge (7-14 days after the operation) to 6 months after the operation, and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week; The control group patients received the same baseline evaluation as the experimental group patients. The control group will not receive phisical exercise intervention, but will receive postoperative nutritional treatment with the same standards as the experimental group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Nutrition Related Cancer, Sarcopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    960 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise and Enteral Nutrition Intervention
    Arm Type
    Experimental
    Arm Description
    A comprehensive postoperative management combined physical exercise intervention with oral nutritional support
    Arm Title
    Enteral Nutrition Intervention
    Arm Type
    Active Comparator
    Arm Description
    The control group will not receive exercise intervention, but will receive postoperative nutritional support treatment with the same standards as the experimental group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise Intervention
    Intervention Description
    Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet.. Exercise: under the guidance of the rehabilitation therapist, the patient gradually recovers Exercise from discharge (7-14 days after the operation) to 6 months after the operation, and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week;
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutrition Intervention
    Intervention Description
    (1) Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet..
    Primary Outcome Measure Information:
    Title
    3-year overall survival rate
    Description
    The 3-year overall survival rate refers to the proportion of gastric cancer patients who have survived for more than 3 years after various comprehensive treatments
    Time Frame
    3 years after surgery
    Secondary Outcome Measure Information:
    Title
    3-year disease-free survival rate
    Description
    The proportion of clinically confirmed complete remission to recurrence within 3 years
    Time Frame
    3 years after surgery
    Title
    Scored Patient-Generated Subjective Global Assessment, PG-SGA
    Description
    Scored Patient-Generated Subjective Global Assessment is the preferred method recommended by the American Dietitian Association for nutritional screening of tumor patients. It can conduct qualitative and quantitative comprehensive evaluation of patients' nutritional status from four aspects: weight loss, disease and age, metabolic stress status, and physical examination. It is a sensitive evaluation scale for patients to malnutrition changes
    Time Frame
    6 months after surgery
    Title
    QLQ-C30 assessment
    Description
    The quality of life of patients 6 months after surgery was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), which can evaluate the quality of life from a multidimensional perspective and better reflect the connotation of quality of life. It is widely used in clinical practice to measure the quality of life of cancer patients.
    Time Frame
    6 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:(1) 18 years ≤ age ≤ 70 years (2) Preoperative Karnofsky physical condition score: 0 or 1 or 2 (3) Preoperative pathological biopsy by gastroscope, histologically confirmed as adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma) (4) Gastric cancer patients diagnosed with clinical stage Ib IIIc through CT, MRI, gastroscopy, and pathology (based on the 8th edition of UICC/AJCC staging) (5) Abdominal enhanced CT/MRI examination showed a clinical staging of cT2-4aN0-3M0 (based on AJCC-8thTNM tumor staging), and standard D2 radical surgery for gastric cancer was performed; (6) Have not received any radiotherapy, chemotherapy or immunotherapy; (7) Hemoglobin ≥ 80g/L; (8) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; (9) Platelets ≥ 75 × 109/L; (10) ALT ≤ 2.5 times the normal upper limit value; (11) AST ≤ 2.5 times the normal upper limit value; (12) ALP ≤ 2.5 times the normal upper limit value; (13) Serum total bilirubin<1.5 times the upper normal limit value; (14) Serum creatinine<1 times the upper normal limit value; (15) Sign written informed consent; Exclusion Criteria: Patients diagnosed with distant metastasis through abdominal lung CT/MRI or PET-CT Pregnant or lactating women People with uncontrolled epilepsy, Central nervous system disease or mental disorders Patients with combined limb disabilities or motor dysfunction; Patients with other malignant diseases in the past five years, excluding cured skin cancer and cervical Carcinoma in situ Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction within the past 6 months Have a history of cerebral infarction or cerebral hemorrhage in the past 6 months Organ transplantation requires immunosuppressive therapy Serious uncontrolled recurrent infections or other serious uncontrolled concomitant diseases The patient has complications of Grade III or above in Clavien Dindo classification or has been hospitalized for more than 14 days after surgery due to various reasons; Urgent surgery required due to tumor emergencies (bleeding, perforation, obstruction) Pulmonary function test FEV1<expected value 50% Received radiotherapy, chemotherapy, or other neoadjuvant treatment before surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mingjie Xia, Dr
    Phone
    86-431-81875601
    Email
    xmj1983@jlu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quan Wang, Dr
    Organizational Affiliation
    The First Hospital of Jilin University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26331988
    Citation
    Tegels JJ, van Vugt JL, Reisinger KW, Hulsewe KW, Hoofwijk AG, Derikx JP, Stoot JH. Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes. J Surg Oncol. 2015 Sep;112(4):403-7. doi: 10.1002/jso.24015. Epub 2015 Aug 31.
    Results Reference
    background
    PubMed Identifier
    31135850
    Citation
    Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.
    Results Reference
    background
    PubMed Identifier
    26732274
    Citation
    Davis JL, Selby LV, Chou JF, Schattner M, Ilson DH, Capanu M, Brennan MF, Coit DG, Strong VE. Patterns and Predictors of Weight Loss After Gastrectomy for Cancer. Ann Surg Oncol. 2016 May;23(5):1639-45. doi: 10.1245/s10434-015-5065-3. Epub 2016 Jan 5.
    Results Reference
    background
    PubMed Identifier
    28222970
    Citation
    Climent M, Munarriz M, Blazeby JM, Dorcaratto D, Ramon JM, Carrera MJ, Fontane L, Grande L, Pera M. Weight loss and quality of life in patients surviving 2 years after gastric cancer resection. Eur J Surg Oncol. 2017 Jul;43(7):1337-1343. doi: 10.1016/j.ejso.2017.01.239. Epub 2017 Feb 9.
    Results Reference
    background
    PubMed Identifier
    28176023
    Citation
    Aoyama T, Sato T, Maezawa Y, Kano K, Hayashi T, Yamada T, Yukawa N, Oshima T, Rino Y, Masuda M, Ogata T, Cho H, Yoshikawa T. Postoperative weight loss leads to poor survival through poor S-1 efficacy in patients with stage II/III gastric cancer. Int J Clin Oncol. 2017 Jun;22(3):476-483. doi: 10.1007/s10147-017-1089-y. Epub 2017 Feb 7.
    Results Reference
    background

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