The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
ConditionCervical Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSHUANG ZHENG JIA, PhD
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- enteral immunonutrition
- standard oral enteral nutrition
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
SHUANG ZHENG JIA, PhD
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov