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

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?

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancers
• Intervention / Treatment: Dietary supplement: enteral immunonutrition; Dietary supplement: standard oral enteral nutrition

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-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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SHUANGZHENG JIA, PhD; Phone Number: 00-86-010-87788276; Email: jiashuangzheng@cicams.ac.cn

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • Cancer Hospital, Chinese Academy of Medical Sciences
    • Contact: SHUANGZHENG JIA, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• Patients who received neoadjuvant chemotherapy or immunotherapy before treatment;
• Patients with concomitant other malignant tumors or a history of malignant tumors;
• Patients with special pathological types of tumors such as cervical small cell carcinoma or neuroendocrine tumors;
• Patients staged as Ⅳb according to the International Federation of Gynecology and Obstetrics(FIGO) 2018 staging system;
• Patients with other severe chronic debilitating diseases, such as severe heart failure (New York Heart Association Class II-IV), severe liver damage (alanine aminotransferase ≥ 3 times the upper limit of normal), severe renal insufficiency (GFR < 30 ml/min*1.73 m²), etc.;
• Eastern Cooperative Oncology Group(ECOG) performance status ≥ 2;
• Presence of other contraindications to CCRT/RT.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immunonutrition; enteral immunonutrition	Dietary supplement: enteral immunonutrition; Patients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal).
Active Comparator: standard nutrition; standard oral enteral nutrition	Dietary supplement: standard oral enteral nutrition; Patients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity	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).	5-6 weeks
DLT-free survival	Time from start of treatment to onset of DLT	5-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance	the proportion of people who complete the prescribed treatment plan	5-6 weeks
Prevalence of malnutrition	assessed by GLIM criteria	5-6 weeks, 3 months post-treatment
Prevalence of sarcopenia	assessed by Skeletal muscle index(SMI) at the third lumbar vertebra(L3-SMI )calculated based on CT	5-6 weeks, 3 months post-treatment
QoL (Quality of life)	Quality of life measured by standardized EORTC quality of life questionnaire(QLQ)-C30	5-6 weeks, 3 months post-treatment
Objective response rate (ORR)	evaluated by RECIST	3 months post-treatment
laboratory tests	inflammation and immune-related indicators	5-6 weeks, 3 months post-treatment
2-year overall survival	the time from the start of treatment until the date of death from any cause	2 years
2-year progression-free survival	the date of the treatment to the date of disease progression or death from any cause in the absence of progression	2 years

Collaborators and Investigators

• Sponsor: SHUANG ZHENG JIA, PhD
• Investigators: Principal Investigator: SHUANGZHENG JIA, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia; Immunonutrition; Cervical cancer; Concurrent chemoradiotherapy; GLIM
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Uterine Cervical Neoplasms; Sarcopenia
• Other Study ID Numbers: NESTLE2022QN-0007

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