Tests a feeding formula during chemoradiotherapy in cervical cancer patients with malnutrition
Compares a special nutrition formula with standard feeding in cervical cancer patients.
Plain-language title generated from the registry record
Registry title: The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with locally advanced cervical cancer who have malnutrition and are having chemoradiotherapy. It tests whether immunonutrition helps compared with standard nutrition support.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Locally advanced cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma), confirmed by exam and imaging; not FIGO 2018 stage IVb
- Earlier treatment
- No chemotherapy or immunotherapy before this treatment (neoadjuvant). Must be undergoing chemoradiotherapy (CCRT/RT).
- Biomarker or test result
- Malnutrition diagnosed by the GLIM criteria
Main reasons for not taking part
- Another cancer now or in the past
- Small cell carcinoma or neuroendocrine tumor of the cervix
- Severe heart, liver or kidney disease
- ECOG performance status 2 or higher
- Other reasons that make chemoradiotherapy unsafe
Read by machine on 9 November 2026.
Where in China
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SHUANG ZHENG JIA, PhD
- Trial code
- NCT06349148
- Record updated
- 5 December 2025
- Original description
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?Read full original descriptionShow less
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?
Inclusion: 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: Patients who received neoadjuvant chemotherapy or immunotherapy before treatment; Patients with concomitant other malignant tumors or a history of malignant tumors; 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; 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; Eastern Cooperative Oncology Group(ECOG) performance status ≥ 2; Presence of other contraindications to CCRT/RT.