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Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pre-rehabilitation
Standard medical care
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Voluntarily participate in clinical research, fully understand and inform this research and sign the Informed Consent Form (ICF), and are willing to follow and have the ability to complete all experimental procedures;
  2. The age when signing the informed consent form is 18 to 65 years old, male or female;
  3. Advanced gastric adenocarcinoma patients diagnosed with clinical stage II-III by CT, MRI, gastroscope and pathology (based on the 8th edition UICC/AJCC staging);
  4. The function of major organs is normal;
  5. No history of gastric cancer surgery, chemotherapy or immunotherapy;
  6. Not accompanied by systemic infection requiring antibiotic treatment;
  7. After general examination, it is planned to undergo neoadjuvant immunotherapy and neoadjuvant chemotherapy followed by surgery;
  8. No contraindications related to CT and MRI examinations;
  9. ECOG score of 0-2 points;

Exclusion Criteria:

  1. The patient has a history of chemotherapy and immunotherapy in the past;
  2. The patient cannot undergo CT or MRI scan, or has artifacts that cannot be assessed;
  3. The patient refuses to participate in the study;
  4. Patients who are going to undergo or have previously received organ or bone marrow transplantation;
  5. The patient is pregnant, breastfeeding or unable to take appropriate contraceptive measures;
  6. Patients with mental illness or related medical history, such as: the patient cannot understand the relevant requirements of this study;
  7. Patients with human immunodeficiency virus (HIV) infection, active pulmonary tuberculosis or other severe, acute and chronic diseases that may increase the risk of participating in research and research drugs, and who are judged by the investigator to be unsuitable for participating in clinical research;
  8. Other relevant factors are considered unsuitable for participating in the research by the researcher.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pre-rehabilitation group

    Conventional group

    Arm Description

    Triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period

    Conventional group

    Outcomes

    Primary Outcome Measures

    6 minutes walking test
    The maximum distance the patient can walk on an unimpeded hard surface in six minutes.
    Scored Patient-Generated Subjective Global Assessment score
    Scored Patient-Generated Subjective Global Assessment(PG-SGA), PG-SGA consists of two parts: patient self-assessment and medical staff assessment. The specific contents include body weight, food intake, symptoms, activity and physical function, the relationship between disease and nutritional needs, metabolic needs, Physical examination and other 7 aspects, the first 4 aspects are evaluated by the patients themselves, and the last 3 aspects are evaluated by the medical staff. The overall evaluation includes qualitative evaluation and quantitative evaluation. Higher scores mean a worse outcome.
    DMSM score
    Distress Management Screening Measure(DMSM), is an assessment tool recommended by the US National Comprehensive Cancer Network for screening the level and possible causes of psychological pain. The DMSM questionnaire consists of two parts: the first part is the Psychological Distress Thermometer (DT). The second part is the problem list (PL), which contains 36 factors.Higher scores mean a worse outcome.

    Secondary Outcome Measures

    Quality of life score QLQ-C30
    Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30 ).
    Quality of life score QLQ-STO22
    Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires ( QLQ-STO22).
    Postoperative skeletal muscle index of the third lumbar spine plane.
    Grip strength (Kg).
    The rate of weight loss (≥10%) .
    The rate of weight loss (≥10%) .
    The incidence of sarcopenia.
    The incidence of sarcopenia.
    The ratio of actual ONS to recommended ONS.
    The ratio of actual ONS to recommended ONS.
    Albumin
    Laboratory test: albumin (g/L)
    Hemoglobin
    Laboratory test: hemoglobin (g/L)
    Prealbumin.
    Laboratory test: prealbumin (g/L)
    Incidence of adverse reactions during neoadjuvant therapy.
    Incidence of adverse reactions during neoadjuvant therapy.
    Completion rate of neoadjuvant therapy for gastric cancer
    Number of completed courses/number of regimen courses
    Surgery rate after neoadjuvant therapy for gastric cancer.
    Surgery rate after neoadjuvant therapy for gastric cancer.
    TRG grading after neoadjuvant therapy for gastric cancer.
    TRG grading after neoadjuvant therapy for gastric cancer.
    R0 resection rate
    R0 resection rate
    Postoperative complication rate of grade IIIa or above.
    Postoperative complication rate of grade IIIa or above.

    Full Information

    First Posted
    June 23, 2022
    Last Updated
    July 24, 2022
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05445401
    Brief Title
    Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
    Official Title
    A Pilot Study of Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2026 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study, patients with traditional neoadjuvant gastric cancer were used as controls to explore whether the triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period before surgery could improve the functional reserve of neoadjuvant gastric cancer patients and accelerate postoperative recovery.
    Detailed Description
    Internationally, pre-rehabilitation strategies have been widely used in surgery. Due to the late start of the concept of enhanced rehabilitation in my country, the research on pre-rehabilitation in my country is still in its infancy, and the research on pre-rehabilitation in gastric cancer is basically in a blank state. Domestic scholars have compared the rehabilitation of gastric cancer patients in the exercise-based pre-rehabilitation group and the postoperative rapid rehabilitation group, and found that the postoperative stress response, insulin resistance, and inflammatory response in the pre-rehabilitation group were lower than those in the conventional treatment group, and their nutritional status was improved. faster. The pre-rehabilitation model of comprehensive exercise, nutritional support and psychological intervention is rarely used in gastric cancer patients, and there is a lack of high-quality clinical data and related research. Neoadjuvant chemotherapy and neoadjuvant chemotherapy combined with immunotherapy are the current research hotspots in locally advanced gastric cancer. The current research studies focus on tumor regression and prognosis and survival. However, the preoperative treatment cycle of neoadjuvant gastric cancer patients is long. If there is a lack of long-term and continuous effective management and guidance during the neoadjuvant therapy, it is very easy to lead to nutritional and nutritional deficiencies after neoadjuvant therapy. The poor physical condition makes the patient suffer from physical and psychological pain. Therefore, we considered whether it is possible to carry out effective, convenient and economical rehabilitation training treatment for neoadjuvant gastric cancer patients before surgery, so as to prevent the occurrence of surgical risks and other complications in the preoperative stage, improve the functional reserve of neoadjuvant gastric cancer patients and respond to surgery. stimulated and accelerated postoperative recovery.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Pre-rehabilitation group
    Arm Type
    Experimental
    Arm Description
    Triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period
    Arm Title
    Conventional group
    Arm Type
    Placebo Comparator
    Arm Description
    Conventional group
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pre-rehabilitation
    Intervention Description
    Triple pre-rehabilitation interventions of exercise, nutrition and psychology
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard medical care
    Intervention Description
    Traditional care
    Primary Outcome Measure Information:
    Title
    6 minutes walking test
    Description
    The maximum distance the patient can walk on an unimpeded hard surface in six minutes.
    Time Frame
    1 month after surgery
    Title
    Scored Patient-Generated Subjective Global Assessment score
    Description
    Scored Patient-Generated Subjective Global Assessment(PG-SGA), PG-SGA consists of two parts: patient self-assessment and medical staff assessment. The specific contents include body weight, food intake, symptoms, activity and physical function, the relationship between disease and nutritional needs, metabolic needs, Physical examination and other 7 aspects, the first 4 aspects are evaluated by the patients themselves, and the last 3 aspects are evaluated by the medical staff. The overall evaluation includes qualitative evaluation and quantitative evaluation. Higher scores mean a worse outcome.
    Time Frame
    1 month after surgery
    Title
    DMSM score
    Description
    Distress Management Screening Measure(DMSM), is an assessment tool recommended by the US National Comprehensive Cancer Network for screening the level and possible causes of psychological pain. The DMSM questionnaire consists of two parts: the first part is the Psychological Distress Thermometer (DT). The second part is the problem list (PL), which contains 36 factors.Higher scores mean a worse outcome.
    Time Frame
    1 month after surgery
    Secondary Outcome Measure Information:
    Title
    Quality of life score QLQ-C30
    Description
    Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30 ).
    Time Frame
    3 month after surgery
    Title
    Quality of life score QLQ-STO22
    Description
    Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires ( QLQ-STO22).
    Time Frame
    3 month after surgery
    Title
    Postoperative skeletal muscle index of the third lumbar spine plane.
    Description
    Grip strength (Kg).
    Time Frame
    3 month after surgery
    Title
    The rate of weight loss (≥10%) .
    Description
    The rate of weight loss (≥10%) .
    Time Frame
    3 month after surgery
    Title
    The incidence of sarcopenia.
    Description
    The incidence of sarcopenia.
    Time Frame
    3 month after surgery
    Title
    The ratio of actual ONS to recommended ONS.
    Description
    The ratio of actual ONS to recommended ONS.
    Time Frame
    3 month after surgery
    Title
    Albumin
    Description
    Laboratory test: albumin (g/L)
    Time Frame
    3 month after surgery
    Title
    Hemoglobin
    Description
    Laboratory test: hemoglobin (g/L)
    Time Frame
    3 month after surgery
    Title
    Prealbumin.
    Description
    Laboratory test: prealbumin (g/L)
    Time Frame
    3 month after surgery
    Title
    Incidence of adverse reactions during neoadjuvant therapy.
    Description
    Incidence of adverse reactions during neoadjuvant therapy.
    Time Frame
    1 month after surgery
    Title
    Completion rate of neoadjuvant therapy for gastric cancer
    Description
    Number of completed courses/number of regimen courses
    Time Frame
    1 month after surgery
    Title
    Surgery rate after neoadjuvant therapy for gastric cancer.
    Description
    Surgery rate after neoadjuvant therapy for gastric cancer.
    Time Frame
    1 month after surgery
    Title
    TRG grading after neoadjuvant therapy for gastric cancer.
    Description
    TRG grading after neoadjuvant therapy for gastric cancer.
    Time Frame
    1 month after surgery
    Title
    R0 resection rate
    Description
    R0 resection rate
    Time Frame
    1 month after surgery
    Title
    Postoperative complication rate of grade IIIa or above.
    Description
    Postoperative complication rate of grade IIIa or above.
    Time Frame
    3 month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Voluntarily participate in clinical research, fully understand and inform this research and sign the Informed Consent Form (ICF), and are willing to follow and have the ability to complete all experimental procedures; The age when signing the informed consent form is 18 to 65 years old, male or female; Advanced gastric adenocarcinoma patients diagnosed with clinical stage II-III by CT, MRI, gastroscope and pathology (based on the 8th edition UICC/AJCC staging); The function of major organs is normal; No history of gastric cancer surgery, chemotherapy or immunotherapy; Not accompanied by systemic infection requiring antibiotic treatment; After general examination, it is planned to undergo neoadjuvant immunotherapy and neoadjuvant chemotherapy followed by surgery; No contraindications related to CT and MRI examinations; ECOG score of 0-2 points; Exclusion Criteria: The patient has a history of chemotherapy and immunotherapy in the past; The patient cannot undergo CT or MRI scan, or has artifacts that cannot be assessed; The patient refuses to participate in the study; Patients who are going to undergo or have previously received organ or bone marrow transplantation; The patient is pregnant, breastfeeding or unable to take appropriate contraceptive measures; Patients with mental illness or related medical history, such as: the patient cannot understand the relevant requirements of this study; Patients with human immunodeficiency virus (HIV) infection, active pulmonary tuberculosis or other severe, acute and chronic diseases that may increase the risk of participating in research and research drugs, and who are judged by the investigator to be unsuitable for participating in clinical research; Other relevant factors are considered unsuitable for participating in the research by the researcher.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meng Li
    Phone
    18569951013
    Email
    lm17@mails.jlu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quan Wang
    Organizational Affiliation
    The First Hospital of Jilin University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer

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