Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer

NCT05445401 | Not Yet Recruiting

• 1 other identifier: STARS-GC06
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• Quality of life score QLQ-C30

  3 month after surgery

• Quality of life score QLQ-STO22

  3 month after surgery

• Postoperative skeletal muscle index of the third lumbar spine plane.

  3 month after surgery

• The rate of weight loss (≥10%) .

  3 month after surgery

• The incidence of sarcopenia.

  3 month after surgery

Study Arms (2)

Pre-rehabilitation group

EXPERIMENTAL

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

Behavioral: Pre-rehabilitation

Conventional group

PLACEBO COMPARATOR

Conventional group

Behavioral: Standard medical care

Interventions

Pre-rehabilitation BEHAVIORAL

Triple pre-rehabilitation interventions of exercise, nutrition and psychology

Pre-rehabilitation group

Standard medical care BEHAVIORAL

Traditional care

Conventional group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Quan Wang

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Li

CONTACT

18569951013; lm17@mails.jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 6, 2022
• Study Start: August 1, 2022
• Primary Completion: June 30, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share