NCT06349148Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 31 Mar 2024
- Start date
- Jan 2024
- Primary completion date
- Aug 2026
- Lead sponsor
- SHUANG ZHENG JIA, PhD
- Diseases
- Cervical cancer
- NCT number
- NCT06349148
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Jan 2024 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received neoadjuvant chemotherapy or immunotherapy before treatment;
Other illness
- Patients with concomitant other malignant tumors or a history of malignant tumors;
Lab values
- 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.;
Other
- 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.
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.