Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349148
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-31
Brief Title:
The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
Sponsor:
SHUANGZHENGJIA
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 supportThe main purpose it aims to answer are1Can immunonutrition therapy improve patients dose-limiting toxicityDLT and DLT-free survival 2Can immunonutrition therapy improve patients nutritional status and quality of life
Detailed Description:
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-W5GLIM 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 50 score was used for treatment side effects
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-W5GLIM 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 50 score was used for treatment side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None