Neoplasms

Digestive System Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Malnutrition

Postoperative Complications

Nutrition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Stomach Diseases

Stomach Cancer

Esophageal Cancer

The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \</≥15 kg/m2 for females and \</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the normal FFMI group (FFMI ≥17 kg/m2 for male and FFMI ≥15 kg/m2 for female).

The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \</≥15 kg/m2 for females and \</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the low FFMI group (FFMI \<17 kg/m2 for male and FFMI \<15 kg/m2 for female).

no intervention

The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.

The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.

Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.

GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

postoperative complications (infectious complications and noninfectious complications)

nutritional status ( such as: weight，albumin，prealbumin)

hospitalization cost(including: surgery and medicine costs)

Jiangsu Cancer Institute & Hospital

Subei People's Hospital of Jiangsu Province

Peking Union Medical College

Jinling Hospital, China

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Uterine Cervical Neoplasms

Sarcopenia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

Patients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal).

enteral immunonutrition

Patients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison).

standard oral enteral nutrition

SHUANGZHENG JIA, PhD

SHUANGZHENG JIA

The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life?

Malnutrition is one of the most common complications in patients with Locally Advanced Cervical Cancer (LACC) undergoing radical concurrent chemoradiotherapy (CCRT). Tumor patients often experience significant immune imbalance, metabolic abnormalities, and inflammatory responses. Immunonutrition therapy involves the use of specific immunonutrients such as polyunsaturated fatty acids, arginine, nucleotides, etc., to prevent and correct malnutrition in cancer patients, regulate immune function, alleviate harmful or excessive inflammatory responses, and thereby improve patients' clinical outcomes.

This study is an open-label randomized controlled trial, including patients with LACC who all receive radical radiotherapy. Using the Nutritional Risk Screening 2002 (NRS2002) at screening, patients identified as having nutritional risk are further assessed by nutritionists and physicians using the Patient-Generated Subjective Global Assessment (PG-SGA) score and modified Global leadership initiative on malnutrition (GLIM) criteria. Patients with moderate or severe malnutrition are randomly allocated into the enteral immunonutrition therapy group (experimental group) and the standard enteral nutrition support group (control group). The experimental group receives immunonutrients per day, while the control group receives isoenergetic standard oral enteral nutrition. Upon admission, all patients receive nutritional education from specialized nurses and consult with nutritionists, and nutritional support is provided during the concurrent chemoradiotherapy for a total of 5 weeks (W0-W5).GLIM score, quality of life score and peripheral blood inflammation and immune indicators were collected within 48 hours after admission (before treatment), W5, W8, and W20; CTCAE v 5.0 score was used for treatment side effects.

The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients

The Effects of Immunonutrition Therapy on the Nutritional Status, Immune Function, and Quality of Life of Locally Advanced Cervical Cancer Patients With Malnutrition: an Open-label Randomized Controlled Study

Patients need to receive cisplatin treatment at 40 mg/m2 weekly for 5-6 weeks. During this period, any serious adverse reactions that lead to treatment interruption, delay, or chemotherapy dose reduction are defined as dose-limiting toxicities(DLT).

Time from start of treatment to onset of DLT

the proportion of people who complete the prescribed treatment plan

assessed by Skeletal muscle index(SMI) at the third lumbar vertebra(L3-SMI )calculated based on CT

Quality of life measured by standardized EORTC quality of life questionnaire(QLQ)-C30

inflammation and immune-related indicators

the time from the start of treatment until the date of death from any cause

the date of the treatment to the date of disease progression or death from any cause in the absence of progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer	NCT05088304	Cancer of Stoma... Cancer of Esoph... Malnutrition Muscle Loss	no intervention	18 Years -	Jinling Hospital, China
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer	NCT05088304	Cancer of Stoma... Cancer of Esoph... Malnutrition Muscle Loss	no intervention	18 Years -	Jinling Hospital, China
The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients	NCT06349148	Cervical Cancer...	enteral immunon... standard oral e...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer	NCT05088304	Cancer of Stoma... Cancer of Esoph... Malnutrition Muscle Loss	no intervention	18 Years -	Jinling Hospital, China

Spots Global Cancer Trial Database for glim

Every month we try and update this database with for glim cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for glim

Every month we try and update this database with for glim cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for glim cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.