RecruitingNot ApplicableNCT06349148

The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients

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


Sponsor

SHUANG ZHENG JIA, PhD

Enrollment

50 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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?


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether special nutritional support (called immunonutrition) helps improve outcomes for people with locally advanced cervical cancer who are receiving radiation and/or chemotherapy. **You may be eligible if...** - You are 18 or older and have been diagnosed with cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer is classified as locally advanced - You are currently receiving chemotherapy with radiation or radiation alone - You have been assessed as malnourished using standard criteria - You are able to communicate and answer questions **You may NOT be eligible if...** - You received chemotherapy or immunotherapy before your current treatment - You have another active cancer or history of another cancer - Your cancer is a rare type (small cell cervical cancer or neuroendocrine tumor) - Your cancer is stage IV (spread to distant organs) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTenteral immunonutrition

Patients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal).

DIETARY_SUPPLEMENTstandard oral enteral nutrition

Patients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison).


Locations(1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

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NCT06349148


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