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The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients

ConditionCervical Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSHUANG ZHENG JIA, PhD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • enteral immunonutrition

    Dietary supplement

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

  • standard oral enteral nutrition

    Dietary supplement

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: immunonutritionExperimental treatment 1 intervention
Group B: standard nutritionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
5-6 weeks
2

DLT-free survival

Time from start of treatment to onset of DLT

Time frame
5-6 weeks

Secondary outcomes

1

compliance

the proportion of people who complete the prescribed treatment plan

Time frame
5-6 weeks
2

Prevalence of malnutrition

assessed by GLIM criteria

Time frame
5-6 weeks, 3 months post-treatment
3

Prevalence of sarcopenia

assessed by Skeletal muscle index(SMI) at the third lumbar vertebra(L3-SMI )calculated based on CT

Time frame
5-6 weeks, 3 months post-treatment
4

QoL (Quality of life)

Quality of life measured by standardized EORTC quality of life questionnaire(QLQ)-C30

Time frame
5-6 weeks, 3 months post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SHUANG ZHENG JIA, PhD

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Source ClinicalTrials.gov
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