Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer

A Pilot Study of Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Behavioral: Pre-rehabilitation; Behavioral: Standard medical care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meng Li; Phone Number: 18569951013; Email: lm17@mails.jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pre-rehabilitation group; Triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period	Behavioral: Pre-rehabilitation; Triple pre-rehabilitation interventions of exercise, nutrition and psychology
PLACEBO_COMPARATOR: Conventional group	Behavioral: Standard medical care; Traditional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walking test	The maximum distance the patient can walk on an unimpeded hard surface in six minutes.	1 month after surgery
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.	1 month after surgery
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.	1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score QLQ-C30	Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30 ).	3 month after surgery
Quality of life score QLQ-STO22	Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires ( QLQ-STO22).	3 month after surgery
Postoperative skeletal muscle index of the third lumbar spine plane.	Grip strength (Kg).	3 month after surgery
The rate of weight loss (≥10%) .	The rate of weight loss (≥10%) .	3 month after surgery
The incidence of sarcopenia.	The incidence of sarcopenia.	3 month after surgery
The ratio of actual ONS to recommended ONS.	The ratio of actual ONS to recommended ONS.	3 month after surgery
Albumin	Laboratory test: albumin （g/L）	3 month after surgery
Hemoglobin	Laboratory test: hemoglobin (g/L)	3 month after surgery
Prealbumin.	Laboratory test: prealbumin (g/L)	3 month after surgery
Incidence of adverse reactions during neoadjuvant therapy.	Incidence of adverse reactions during neoadjuvant therapy.	1 month after surgery
Completion rate of neoadjuvant therapy for gastric cancer	Number of completed courses/number of regimen courses	1 month after surgery
Surgery rate after neoadjuvant therapy for gastric cancer.	Surgery rate after neoadjuvant therapy for gastric cancer.	1 month after surgery
TRG grading after neoadjuvant therapy for gastric cancer.	TRG grading after neoadjuvant therapy for gastric cancer.	1 month after surgery
R0 resection rate	R0 resection rate	1 month after surgery
Postoperative complication rate of grade IIIa or above.	Postoperative complication rate of grade IIIa or above.	3 month after surgery

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Quan Wang, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): June 30, 2026

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (ACTUAL): July 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: STARS-GC06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No