Investigating the Correlation Between Pre-Treatment Imaging-Derived Body Composition, Chemotherapy Dose Adjustment, and Treatment Efficacy in Gynecological Cancer Patients "

ConditionSearch MeSH
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorNational Cheng-Kung University Hospital

About this trial

The dosage of paclitaxel, an adjuvant chemotherapy agent for endometrial and ovarian cancer, is typically calculated based on the patient's body surface area (BSA). However, cancer patients with the same BSA may exhibit significant differences in body composition, which could influence the distribution pattern of paclitaxel in the body. These variations may lead to individual differences in drug tolerance and adverse effects. Such variability not only impacts the patient's treatment experience and quality of life but may also increase medical costs, including hospitalization, emergency department visits, and additional treatments required to manage chemotherapy-induced toxicities.

Our preliminary study results indicate that skeletal muscle area (SMA) and skeletal muscle index (SMI), as assessed through computed tomography (CT) imaging, are significantly associated with the incidence of Grade 3 or higher leukopenia or neutropenia following the first two cycles of chemotherapy in patients with endometrial cancer. Furthermore, the predictive accuracy of these CT-derived muscle measurements surpasses the clinical judgment made by physicians based on conventional treatment guidelines. Patients who develop Grade 3 or higher leukopenia or neutropenia during the first two cycles are more likely to experience more frequent occurrences of Grade 3 or higher chemotherapy-related adverse effects in subsequent treatment cycles.

However, no study has comprehensively investigated the relationship between body composition, chemotherapy dosing, and adverse effects. Therefore, this trial aims to examine the impact of body composition on chemotherapy dose adjustments and adverse effects. By utilizing body composition data extracted from abdominal CT imaging through this product, this study seeks to establish a risk stratification tool to assist physicians in treating patients with endometrial and ovarian cancer by providing a reference for chemotherapy dose reduction.

It is expected that through a precision chemotherapy strategy, the incidence of chemotherapy-related adverse effects can be reduced, thereby lowering medical resource expenditures incurred from managing these adverse effects, such as emergency department visits, hospitalizations, additional diagnostic tests, and supportive medication costs. Furthermore, this approach aims to improve patients' health-related quality of life and achieve a dual benefit of medical economic efficiency and clinical effectiveness.

Eligibility criteria

Qualifiers

Able to comprehend and willing to participate in this clinical trial, with signed informed consent.

Underwent an abdominal computed tomography (CT) scan within three months prior to surgical treatment, with a non-contrast-enhanced single-slice image at the third lumbar vertebral level available for body composition analysis.

Histologically or cytologically confirmed diagnosis of endometrial cancer or ovarian cancer.

Age between 20 and 80 years.

Disqualifiers

Motion artifacts due to poor patient compliance.

Noticeable scoliosis or kyphosis.

Multiple lumbar vertebral compression fractures.

Significant generalized edema.

Trial design

Treatments tested in this trial

  • National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis Software

Treatment groups

294 Participants
are divided into 2 treatment groups