cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cance cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who provided written informed consent of their own free will after receiving sufficient explanation and demonstrating adequate understanding of study participation. 2. Patients aged 20 years or older and younger than 75 years at the time of consent. 3. Patients with histologically confirmed primary gynecologic cancer (cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). 4. Patients deemed appropriate candidates for TC (paclitaxel/carboplatin) therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. 6. Patients with adequate bone marrow function, hepatic function, and renal function.
Exclusion criteria
Exclusion criteria: 1. Patients with pre-existing peripheral neuropathy (CTCAE grade 2 or higher). 2. Patients with a history of prior chemotherapy 3. Patients deemed inappropriate for study participation by the principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of CIPN incidence and severity changes between control and intervention groups using CTCAE v5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Correlation between serum zinc levels and incidence and severity of CIPN. 2. Comparison of changes in CIPN incidence and severity between control and intervention groups using the Japanese version of FACT/GOG-NTx questionnaire. 3. Incidence and severity of CIPN during TC therapy. 4. Changes in serum zinc levels compared to baseline. 5. Progression-Free Survival (PFS) 6. Response Rate (RR) | — |
Contacts
Fujita Health University Okazaki Medical Center