The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients

NCT06349148 | Recruiting

• 1 other identifier: NESTLE2022QN-0007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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?

Conditions

Cervical Cancers

Keywords

Cervical cancer; Immunonutrition; Concurrent chemoradiotherapy; GLIM; Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• compliance

  5-6 weeks

• Prevalence of malnutrition

  5-6 weeks, 3 months post-treatment

• Prevalence of sarcopenia

  5-6 weeks, 3 months post-treatment

• QoL (Quality of life)

  5-6 weeks, 3 months post-treatment

• Objective response rate (ORR)

  3 months post-treatment

Study Arms (2)

immunonutrition

EXPERIMENTAL

enteral immunonutrition

Dietary Supplement: enteral immunonutrition

standard nutrition

ACTIVE COMPARATOR

standard oral enteral nutrition

Dietary Supplement: standard oral enteral nutrition

Interventions

standard oral enteral nutrition DIETARY_SUPPLEMENT

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

standard nutrition

enteral immunonutrition DIETARY_SUPPLEMENT

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

immunonutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• SHUANG ZHENG JIA, PhD: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• SHUANGZHENG JIA

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SHUANGZHENG JIA, PhD

CONTACT

00-86-010-87788276; jiashuangzheng@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)