Cervical Cancer, Endometrial Cancer, Ovarian Cancer
Conditions
Keywords
Immune tolerance induction, Desensitization, Drug hypersensitivity, Chemotherapy
Brief summary
The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer. The main questions it aims to answer are: \- Does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles? Participants will: * Undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment. * Receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.
Detailed description
Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. It follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. However, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.
Interventions
OTHERProactive immune tolerance induction
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
OTHERStandard Treatment
Standard treatment throughout all chemotherapy cycles
A chemotherapy regimen for gynecologic cancers.
DRUGStandard premedication (20 mg)
Premedication includes 20 mg of dexamethasone.
DRUGReduced premedication (10 mg)
Premedication includes 20 mg of dexamethasone.
DRUGReduced premedication (5 mg)
Premedication includes 5 mg of dexamethasone.
Sponsors
Seoul National University Bundang Hospital
Seoul National University Boramae Hospital
Korea Health Industry Development Institute
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A randomized, placebo-controlled, parallel-group, open-label, clinical trial
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies. * Patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin. * Patients who are able to read and voluntarily provide written informed consent. * Aged 19 years or older.
Exclusion criteria
* Patients who do not wish to participate in this study voluntarily. * Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypersensitivity reaction incidence | From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions). | Hypersensitivity reaction incidence (%) is calculated as (number of hypersensitivity reaction cases / total chemotherapy administrations) × 100. Hypersensitivity reaction will be defined as a Grade ≥2 event according to Common Terminology Criteria for Adverse Events (CTCAE), or a moderate or higher event according to Brown's criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of hypersensitivity reaction | From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions). | Severity of hypersensitivity reactions will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE). |
| Patients' quality of life | From chemotherapy initiation to the last cycle, an average of 6 months | Patients' quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores indicate better outcomes for the Global Health Status and Functional Scales, whereas higher scores on the Symptom Scales indicate worse symptoms. |
| Chemotherapy completion rate | From chemotherapy initiation to the last cycle in each patient, an average of 6 months | Chemotherapy completion rate is defined as the proportion of patients who completed all planned chemotherapy cycles as originally scheduled at treatment initiation. |
| Survival rate | At study completion in each patient, an average of 1 year | Survival rate is defined as the proportion of patients who remain alive, with or without disease, after completion of the planned chemotherapy. |
| Recurrence Rate | At study completion in each patient, an average of 1 year | Recurrence rate is defined as the proportion of patients who experience a return of disease after achieving a response to treatment. |
| Tumor Response Rate | At every third chemotherapy cycle in each patient | Tumor response rate is defined as the proportion of patients who experience tumor size reduction or disappearance in response to chemotherapy. It is calculated as the proportion of patients who achieve a complete response (disappearance of all tumors with no evidence of new lesions) or a partial response (at least a 30% reduction in the size of tumors, with no appearance of new lesion) after planned chemotherapy. |
Countries
South Korea
Contacts
Primary ContactHye-Ryun Kang, MD, PhD
Backup ContactJiyeon Park, MD
Outcome results
None listed