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
About this trial
This is an interventional treatment trial for Gastric Cancer
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.
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
NCT ID
NCT05445401
First Posted
June 23, 2022
Last Updated
July 24, 2022
Sponsor
The First Hospital of Jilin University
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
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Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
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