Clinical trial NCT06349148: The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancers
Keywords: Cervical cancer
Immunonutrition
Concurrent chemoradiotherapy
GLIM
Sarcopenia
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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?

Detailed description: Malnutrition is one of the most common complications in patients with Locally Advanced Cervical Cancer (LACC) undergoing radical concurrent chemoradiotherapy (CCRT). Tumor patients often experience significant immune imbalance, metabolic abnormalities, and inflammatory responses. Immunonutrition therapy involves the use of specific immunonutrients such as polyunsaturated fatty acids, arginine, nucleotides, etc., to prevent and correct malnutrition in cancer patients, regulate immune function, alleviate harmful or excessive inflammatory responses, and thereby improve patients' clinical outcomes.

This study is an open-label randomized controlled trial, including patients with LACC who all receive radical radiotherapy. Using the Nutritional Risk Screening 2002 (NRS2002) at screening, patients identified as having nutritional risk are further assessed by nutritionists and physicians using the Patient-Generated Subjective Global Assessment (PG-SGA) score and modified Global leadership initiative on malnutrition (GLIM) criteria. Patients with moderate or severe malnutrition are randomly allocated into the enteral immunonutrition therapy group (experimental group) and the standard enteral nutrition support group (control group). The experimental group receives immunonutrients per day, while the control group receives isoenergetic standard oral enteral nutrition. Upon admission, all patients receive nutritional education from specialized nurses and consult with nutritionists, and nutritional support is provided during the concurrent chemoradiotherapy for a total of 5 weeks (W0-W5).GLIM score, quality of life score and peripheral blood inflammation and immune indicators were collected within 48 hours after admission (before treatment), W5, W8, and W20; CTCAE v 5.0 score was used for treatment side effects.

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.

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: 5-6 weeks
measure: DLT-free survival
timeFrame: 5-6 weeks
Secondary outcomes:
measure: compliance
timeFrame: 5-6 weeks
measure: Prevalence of malnutrition
timeFrame: 5-6 weeks, 3 months post-treatment
measure: Prevalence of sarcopenia
timeFrame: 5-6 weeks, 3 months post-treatment
measure: QoL (Quality of life)
timeFrame: 5-6 weeks, 3 months post-treatment
measure: Objective response rate (ORR)
timeFrame: 3 months post-treatment
measure: laboratory tests
timeFrame: 5-6 weeks, 3 months post-treatment
measure: 2-year overall survival
timeFrame: 2 years
measure: 2-year progression-free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: SHUANGZHENG JIA
role: PRINCIPAL_INVESTIGATOR
References: