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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunonutrition | Experimental | enteral immunonutrition |
|
| standard nutrition | Active Comparator | standard oral enteral nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral immunonutrition | Dietary Supplement | Patients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | Patients need to receive cisplatin treatment at 40 mg/m2 weekly for 5-6 weeks. During this period, any serious adverse reactions that lead to treatment interruption, delay, or chemotherapy dose reduction are defined as dose-limiting toxicities(DLT). | 5-6 weeks |
| DLT-free survival | Time from start of treatment to onset of DLT | 5-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| compliance | the proportion of people who complete the prescribed treatment plan | 5-6 weeks |
| Prevalence of malnutrition | assessed by GLIM criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SHUANGZHENG JIA, PhD | Contact | 00-86-010-87788276 | jiashuangzheng@cicams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| SHUANGZHENG JIA | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | 100021 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| standard oral enteral nutrition | Dietary Supplement | Patients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison). |
|
| 5-6 weeks, 3 months post-treatment |
| Prevalence of sarcopenia | assessed by Skeletal muscle index(SMI) at the third lumbar vertebra(L3-SMI )calculated based on CT | 5-6 weeks, 3 months post-treatment |
| QoL (Quality of life) | Quality of life measured by standardized EORTC quality of life questionnaire(QLQ)-C30 | 5-6 weeks, 3 months post-treatment |
| Objective response rate (ORR) | evaluated by RECIST | 3 months post-treatment |
| laboratory tests | inflammation and immune-related indicators | 5-6 weeks, 3 months post-treatment |
| 2-year overall survival | the time from the start of treatment until the date of death from any cause | 2 years |
| 2-year progression-free survival | the date of the treatment to the date of disease progression or death from any cause in the absence of progression | 2 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |