Effects of immunonutrition on patients with advanced cervical cancer

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

This study is testing if a special nutrition therapy can help people with advanced cervical cancer feel better and handle their treatment side effects while they are receiving chemotherapy and radiation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06349148 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of locally advanced cervical cancer and diagnosed malnutrition.

Not a fit: Patients with advanced stages of cervical cancer (stage IVb) or those with other severe chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the nutritional status and overall quality of life for patients with advanced cervical cancer undergoing treatment.

How similar studies have performed: Other studies have shown promising results with immunonutrition approaches in cancer care, suggesting potential for success in this trial.

Eligibility criteria

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 this trial is running

Beijing

• 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

Conditions: Cervical Cancers, Cervical cancer, Immunonutrition, Concurrent chemoradiotherapy, GLIM, Sarcopenia