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.

Safety and Efficacy of high dose inorganic seLenium for preventing chemotherapy induced pEripheral Neuropathy in platINUM sensitive recurrent ovarian, fallopian, primary peritoneal cancer: phase III randomized controlled trial (SELENIUM trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004548

Enrollment

Registered

2019-12-12

Start date

2019-12-24

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients enrolled in this study will be randomized into two groups. Patients in the control group will receive paclitaxel chemotherapy every 3 weeks for a total of 6 cycles and a dose of normal

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Frequency of chemo-induced peripheral neuropathy	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactSoo Jin Park

Seoul National University Hospital

soojin.mdpark@gmail.com+82-2-2072-2388

Outcome results