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
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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?

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years;

• Pathological histological diagnosis confirmed as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;

• Confirmed as Locally Advanced Cervical Cancer (LACC) based on gynecological examination and imaging assessment;

• Undergoing CCRT/RT treatment;

• Patients are conscious, able to communicate without barriers, and able to answer questions.

• diagnosed with malnutrition according to the GLIM criteria;

Locations
Other Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
SHUANGZHENG JIA, PhD
jiashuangzheng@cicams.ac.cn
00-86-010-87788276
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Experimental: immunonutrition
enteral immunonutrition
Active_comparator: standard nutrition
standard oral enteral nutrition
Related Therapeutic Areas
Sponsors
Leads: SHUANGZHENGJIA

This content was sourced from clinicaltrials.gov