Using imaging to predict malnutrition in cervical cancer patients

Development and Validation of a CT-Based Radiomics Nomogram for the Prediction of Postoperative Malnutrition in Stage IB1-IIA2 Cervical Cancer (Nutrition Helper-1).

This study is testing if special imaging of a muscle in the back can help doctors predict malnutrition in women with early-stage cervical cancer who have had treatment.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05709769 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze radiomics features of the psoas muscle at the L3 vertebra level to develop a CT-based nomogram for predicting malnutrition in patients with stage IB1-IIA2 cervical cancer who have undergone postoperative radiotherapy or chemoradiotherapy. By utilizing the Patient-Generated Subjective Global Assessment (PG-SGA) scores, the study seeks to enhance early identification of malnutrition, which is crucial for improving patient outcomes. The research builds on previous findings that demonstrated the potential of radiomics in generating imaging biomarkers for clinical decision support.

Who should consider this trial

Good fit: Ideal candidates include patients with FIGO stage IB1-IIA2 cervical cancer who have undergone radical surgery and are receiving postoperative radiotherapy or chemoradiotherapy.

Not a fit: Patients with advanced cervical cancer beyond stage IIA2 or those who have received prior treatments before radical surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved nutritional support and better therapeutic tolerance for cervical cancer patients.

How similar studies have performed: Previous studies have shown promise in using radiomics for predicting malnutrition, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients received pelvic lymphadenectomy and radical hysterectomy, and pathological diagnosis of CC;
2. Patients had stage IB1-IIA2 CC based on the 2014 FIGO staging system for cervical cancer;
3. Patients received postoperative RT/CRT within one week after admission at the ZJPPH;
4. Patients must have Eastern Cooperative Oncology Group performance status 0-2;
5. No treatments prior to radical surgery;
6. Normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin of ≥ 80g/L (can be transfused with red blood cells pre-study), an white blood cell (WBC) counts of ≥ 3.0×109/L，a neutrophil count of ≥ 2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤ 1.0 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤ 2.5 UNL, Alkaline phosphatase (AKP) ≤5.0 UNL. and no major electrocardiogram abnormalities.
7. Patient does not have a known allergy to platinum (cisplatin or carboplatin) or compounds of similar biologic composition.
8. Patients must be with good compliance and agree to accept nutritional therapy;
9. Informed consent signed. -

Exclusion Criteria:

1. Poor image quality or visible artifacts around the L3 psoas;
2. Prior treatments of chemotherapy or irradiation;
3. Poor bone marrow, liver and kidney functions, which would make chemotherapy or radiotherapy intolerable;
4. Participating in other clinical trials;
5. Pregnancy, breast feeding, or not adopting birth control;
6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
7. The subject has had another active malignancy within the past five years;
8. Poor image quality or visible artifacts around the L3 psoas. -

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Hong'en Xu, M.D.

Conditions Cervical Cancer; Malnutrition; Radiomics; Nomogram; Prediction