Effects of immunonutrition on patients with advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label randomized control trial investigates the impact of immunonutrition therapy on patients with locally advanced cervical cancer (LACC) undergoing concurrent chemoradiotherapy. Participants will be divided into two groups: one receiving enteral immunonutrition therapy and the other receiving standard enteral nutrition support. The study aims to determine if immunonutrition can reduce dose-limiting toxicity and improve nutritional status and quality of life for these patients. Assessments will include nutritional risk screening and subjective global assessments to ensure appropriate patient selection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Principal investigator: Shuangzheng Jia — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: SHUANGZHENG JIA, PhD
• Email: jiashuangzheng@cicams.ac.cn
• Phone: 00-86-010-87788276

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.