Cervical Cancers Clinical Trial
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
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?
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 ?b 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. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing |
Lead Sponsor | Collaborator |
---|---|
SHUANGZHENGJIA |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | DLT-free survival | Time from start of treatment to onset of DLT | 5-6 weeks | |
Secondary | compliance | the proportion of people who complete the prescribed treatment plan | 5-6 weeks | |
Secondary | Prevalence of malnutrition | assessed by GLIM criteria | 5-6 weeks, 3 months post-treatment | |
Secondary | 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 | |
Secondary | QoL (Quality of life) | Quality of life measured by standardized EORTC quality of life questionnaire(QLQ)-C30 | 5-6 weeks, 3 months post-treatment | |
Secondary | Objective response rate (ORR) | evaluated by RECIST | 3 months post-treatment | |
Secondary | laboratory tests | inflammation and immune-related indicators | 5-6 weeks, 3 months post-treatment | |
Secondary | 2-year overall survival | the time from the start of treatment until the date of death from any cause | 2 years | |
Secondary | 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 |
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