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
SHUANG ZHENG JIA, PhD
50 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria7
- 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.
Interventions
Patients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal).
Patients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison).
Locations(1)
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NCT06349148