Cervical CancersNCT06349148
The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
A study testing enteral immunonutrition and standard oral enteral nutrition in people with Cervical Cancers, run by SHUANG ZHENG JIA, PhD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- enteral immunonutrition and standard oral enteral nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
SHUANGZHENG JIA, PhD
About this study
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?
Read the 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.
- Conditions
- Cervical Cancers
- Being tested
- enteral immunonutrition, standard oral enteral nutrition
- Keywords
- Cervical cancer, Immunonutrition, Concurrent chemoradiotherapy, GLIM, Sarcopenia
- Medical subject headings
- Uterine Cervical Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral immunonutritionDietary supplement
Patients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal).
standard oral enteral nutritionDietary supplement
Patients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison).
| Study group | Role | What they receive |
|---|---|---|
| immunonutrition | Experimental | enteral immunonutrition Receives: Dietary Supplement: enteral immunonutrition |
| standard nutrition | Active comparator | standard oral enteral nutrition Receives: Dietary Supplement: standard oral enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5-6 weeks
DLT-free survival
Time from start of treatment to onset of DLT
Measured: 5-6 weeks
Secondary outcomes (8)
compliance
the proportion of people who complete the prescribed treatment plan
Measured: 5-6 weeks
Prevalence of malnutrition
assessed by GLIM criteria
Measured: 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
Measured: 5-6 weeks, 3 months post-treatment
QoL (Quality of life)
Quality of life measured by standardized EORTC quality of life questionnaire(QLQ)-C30
Measured: 5-6 weeks, 3 months post-treatment
Objective response rate (ORR)
evaluated by RECIST
Measured: 3 months post-treatment
laboratory tests
inflammation and immune-related indicators
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SHUANG ZHENG JIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SHUANG ZHENG JIA, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- SHUANGZHENG JIA, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349148
- Sponsor's protocol ID
- NESTLE2022QN-0007
- Status last verified
- Dec 2025
- First submitted
- 31 Mar 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06349148
- Acronym / sponsor ID
- NESTLE2022QN-0007
- Conditions
- Cervical Cancers
- Keywords
- Cervical cancer, Immunonutrition, Concurrent chemoradiotherapy, GLIM, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SHUANG ZHENG JIA, PhDUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunonutrition | Experimental | Dietary Supplement: enteral immunonutritionenteral immunonutrition |
| standard nutrition | Active comparator | Dietary Supplement: standard oral enteral nutritionstandard oral enteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral immunonutritionPatients in this group receives 2 bottles of immunonutrients per day (Impact, Nestlé, approximately 700 kcal). | Dietary supplement | immunonutrition |
| standard oral enteral nutritionPatients in the control group receives isoenergetic standard oral enteral nutrition ( emulsion or Nutrison). | Dietary supplement | standard nutrition |
Primary outcome
Dose-limiting toxicity
Time frame: 5-6 weeks
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).
DLT-free survival
Time frame: 5-6 weeks
Time from start of treatment to onset of DLT
8 secondary outcomes
compliance
Time frame: 5-6 weeks
Prevalence of malnutrition
Time frame: 5-6 weeks, 3 months post-treatment
Prevalence of sarcopenia
Time frame: 5-6 weeks, 3 months post-treatment
QoL (Quality of life)
Time frame: 5-6 weeks, 3 months post-treatment
Objective response rate (ORR)
Time frame: 3 months post-treatment
laboratory tests
Time frame: 5-6 weeks, 3 months post-treatment
2-year overall survival
Time frame: 2 years
2-year progression-free survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SHUANGZHENG JIA principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral immunonutrition and standard oral enteral nutrition in people with Cervical Cancers, run by SHUANG ZHENG JIA, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SHUANGZHENG JIA, PhD (00-86-010-87788276, jiashuangzheng@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: 5-6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.