The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients

NCT ID: NCT06349148

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

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 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?

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.

Conditions

Cervical Cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

immunonutrition

enteral immunonutrition

Group Type: EXPERIMENTAL

enteral immunonutrition

Intervention Type: DIETARY_SUPPLEMENT

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

standard nutrition

standard oral enteral nutrition

Group Type: ACTIVE_COMPARATOR

standard oral enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

enteral immunonutrition

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

Intervention Type: DIETARY_SUPPLEMENT

standard oral enteral nutrition

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SHUANG ZHENG JIA, PhD

OTHER

Sponsor Role: lead

Responsible Party

SHUANG ZHENG JIA, PhD

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SHUANGZHENG JIA

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

SHUANGZHENG JIA, PhD

Role: CONTACT

jiashuangzheng@cicams.ac.cn

00-86-010-87788276

Facility Contacts

SHUANGZHENG JIA, PhD

Role: primary

Other Identifiers

NESTLE2022QN-0007

Identifier Type: -

Identifier Source: org_study_id