Actively Recruiting
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
Led by SHUANG ZHENG JIA, PhD · Updated on 2025-12-05
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of immunonutrition therapy on patients with locally advanced cervical cancer (LACC) who are undergoing standard concurrent chemoradiotherapy. This open-label randomized controlled trial aims to determine if immunonutrition can reduce dose-limiting toxicity (DLT), improve DLT-free survival, and enhance patients' nutritional status and quality of life. The study focuses on patients with moderate to severe malnutrition, which is common in this population due to cancer and treatment-related complications. Participants are randomly assigned to receive either enteral immunonutrition therapy, consisting of two bottles of immunonutrients daily, or standard isoenergetic oral enteral nutrition. Both groups receive nutritional education and support from specialized nurses and nutritionists during the 5-week concurrent chemoradiotherapy period. Nutritional status, immune function, and quality of life are monitored through assessments before treatment, at 5 weeks, 8 weeks, and 20 weeks. Throughout the study, researchers collect data on dose-limiting toxicity, treatment side effects, quality of life scores, inflammatory and immune system markers, and nutritional assessments. Additional outcomes such as malnutrition and sarcopenia prevalence, laboratory tests, objective response rates, and survival over two years are also evaluated. This comprehensive monitoring aims to assess the impact of immunonutrition on treatment tolerance and overall patient well-being during and after therapy.
CONDITIONS
Brief Title
The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Diagnosis of locally advanced cervical cancer based on gynecological exam and imaging
- Currently undergoing concurrent chemoradiotherapy or radiotherapy
- Conscious and able to communicate without barriers
- Diagnosed with malnutrition according to GLIM criteria
You will not qualify if you...
- Received neoadjuvant chemotherapy or immunotherapy before treatment
- Have other malignant tumors or history of malignant tumors
- Have special tumor types such as cervical small cell carcinoma or neuroendocrine tumors
- Staged as IIIb according to FIGO 2018 staging system
- Have severe chronic diseases like severe heart failure, severe liver damage, or severe renal insufficiency
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
- Presence of other contraindications to concurrent chemoradiotherapy or radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive nutritional education and consult with nutritionists upon admission. They undergo either enteral immunonutrition therapy or standard oral enteral nutrition during concurrent chemoradiotherapy for a total of 5 weeks.
Weekly visits during chemoradiotherapy
Duration - Up to 2 years
Participants are monitored for nutritional status, immune function, quality of life, treatment side effects, and survival outcomes after treatment completion.
Visits at Week 8, Week 20, and periodic assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
S
SHUANGZHENG JIA, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here