enteral immunonutrition: Patients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal).
standard oral enteral nutrition: Patients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison).
Study 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?
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose-limiting toxicity — 5-6 weeks 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).
DLT-free survival — 5-6 weeks Time from start of treatment to onset of DLT
Trial sites (1)
Facility
City
Region
Status
Cancer Hospital, Chinese Academy of Medical Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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