A phase III randomized controlled trial on the safety and efficacy of high dose inorganic selenium to prevent chemotherapy induced peripheral neuropathy in platinum sensitive recurrent ovarian, fallopian, and primary peritoneal cancer.
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0004548
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 68
(1) Informed consent
(2) Age: 19-80 years old
(3) Complete or partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) or Gynecologic Cancer Intergroup criteria in epithelial ovarian cancer, fallopian cancer, or primary peritoneal cancer patients who underwent either surgery or chemotherapy and those who have recurred cancer at least six months after chemotherapy.
(4) Patients who have received paclitaxel chemotherapy for a minimum of 6 cycles and a maximum of 9 cycles
(5) ECOG performance status 0-2
(6) Patients with no other concurrent disease affecting overall survival
(7) Patients with normal hematologic, renal, and liver functions
(8) Patients who understand the contents of the clinical trial and are capable of participating until the end of the trial
(1) Pregnancy or breastfeeding
(2) Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who received secondary debulking surgery.
(3) Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who did not receive Bevacizumab chemotherapy
(4) Patients with other concurrent disease that can affect overall survival (infection, hypertension, diabetes, cardiac disease, etcetera)
(5) Patients with underlying disease (diabetes, neuropathy, brain or bone metastasis) that can induced neuropathy
(6) Patients allergic to selenium
(7) Inappropriate patients by the researcher's decision
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of chemo-induced peripheral neuropathy
- Secondary Outcome Measures
Name Time Method Severity of chemotherapy induced peripheral neuropathy;Evaluation of quality of life;Evaluation of chemotherapy induced toxicity (NCI CTCAE 5.0);Frequency of chemo-induced peripheral neuropathy