Brief Title
High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy
Official Title
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 Randomised Controlled Trial
Brief Summary
This study aims to evaluate the safety and efficacy of high dose inorganic selenium in
preventing and relieving chemotherapy-induced peripheral neuropathy (CIPN) in
platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients. This
study will be conducted as a phase III randomized controlled trial in platinum-sensitive
recurrent ovarian, fallopian, or primary peritoneal cancer patients who are expected to
undergo paclitaxel-carboplatin chemotherapy. A total of 68 patients need to be enrolled in
this study. The primary objective of this study is to evaluate the frequency of
chemotherapy-induced peripheral neuropathy. The secondary objectives are the evaluation of
the severity of peripheral neuropathy and the quality of life to show that selenium is
effective in preventing and relieving peripheral neuropathy induced by paclitaxel. Positive
results in this study will lead to further studies investigating the effect of selenium on
other chemotherapies that can induce peripheral neuropathy.
Detailed Description
High-dose selenium is known to reduce systemic inflammatory responses through antioxidant and
anti-inflammatory effects. Selenium has also been shown in pre-clinical studies to inhibit
chemotherapy-induced peripheral neuropathy through reactive oxygen species mechanisms in
cells. Therefore, the investigators aimed to confirm the effect of preventing high dose
intravenous selenium prior to chemotherapy and to prevent neuropathy caused by chemotherapy.
In this study, the investigators will identify the frequency and severity of CIPN according
to World Health Organization (WHO) criteria. Also, the investigators will assess the
patient's quality of life (QoL), evaluate the effects of the administration of inorganic
selenium on CIPN and QoL, and confirm the safety of high-dose selenium. I would like to.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence of chemotherapy-induced peripheral neuropathy (3m)
Secondary Outcome
Incidence of chemotherapy-induced peripheral neuropathy (baseline, 3wk)
Condition
Chemotherapy-induced Peripheral Neuropathy
Intervention
sodium selenite pentahydrate
Study Arms / Comparison Groups
Experimental group
Description: The patient will receive an intravenous selenium 2000 μg/40 ml dose just before chemotherapy begins every cycle (every 3 weeks for 6 cycles). Afterward, the same dose will be continued during the maintenance period if it is medically required or if the patient desires to do so.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
68
Start Date
December 24, 2019
Completion Date
December 31, 2024
Primary Completion Date
December 31, 2024
Eligibility 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. Eastern Cooperative Oncology Group 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:
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
Gender
Female
Ages
19 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Hee Seung Kim, MD/PhD, +82-02-2072-2388, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT04201561
Organization ID
SELENIUM trial
Responsible Party
Principal Investigator
Study Sponsor
Seoul National University Hospital
Collaborators
Boryung Pharmaceutical Co., Ltd
Study Sponsor
Hee Seung Kim, MD/PhD, Principal Investigator, Seoul National University Hospital
Verification Date
July 2020