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High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy (SELENIUM)

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy, Recurrent Ovarian Carcinoma, Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
sodium selenite pentahydrate
Normal saline
Chemotherapy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring peripheral neuropathy, recurrent ovarian cancer, high-dose inorganic selenium, sodium selenite

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm 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.

The patient will receive an intravenous normal saline 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.

Outcomes

Primary Outcome Measures

Incidence of chemotherapy-induced peripheral neuropathy (3m)
To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.

Secondary Outcome Measures

Incidence of chemotherapy-induced peripheral neuropathy (baseline, 3wk)
To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.
Severity of chemotherapy-induced peripheral neuropathy
To evaluate the severity of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.
Assessment of quality of life1
Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale: 30-126, the higher score means better quality of life
Assessment of quality of life2
Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Chemotherapy Induced Peripheral Neuropathy 20 (EORTC-CIPN20) Scale: 20-80, the higher score mean worse symptom
concomitant medication1
Dosage and usage of concomitant medication (neurontin) for CIPN
concomitant medication2
Dosage and usage of concomitant medication (duloxetine) for CIPN
concomitant medication3
Dosage and usage of concomitant medication (celecoxib) for CIPN
Adverse events 1
Evaluation of chemotherapy-induced toxicity hematologic (ANC, Hb, Plt) and non-hematologic (nausea, vomiting, diarrhea, constipation, hypersensitivity reaction) symptoms are evaluated by Common Terminology Criteria for Adverse Events ver 5.0 by grade
Adverse events 2
Evaluation of any toxicity related to intravenous selenium administration (garlic odor, nausea, vomiting, hypersensitivity reaction) symptoms are evaluated by Common Terminology Criteria for Adverse Events ver 5.0 by grade

Full Information

First Posted
December 8, 2019
Last Updated
June 23, 2023
Sponsor
Seoul National University Hospital
Collaborators
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04201561
Brief Title
High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy
Acronym
SELENIUM
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 24, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Recurrent Ovarian Carcinoma, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords
peripheral neuropathy, recurrent ovarian cancer, high-dose inorganic selenium, sodium selenite

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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 saline 40 ml every cycle before chemotherapy begins. Patients in the experimental group will receive a dose of selenium 2000 μg/40 ml instead every cycle before chemotherapy.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The patient will receive an intravenous normal saline 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.
Intervention Type
Drug
Intervention Name(s)
sodium selenite pentahydrate
Other Intervention Name(s)
Selentab inj. A12CE02
Intervention Description
High-dose inorganic selenium (2000 μg/40 ml) will be administered before chemotherapy in patients assigned to the experimental group.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
sodium chloride 0.9%
Intervention Description
Normal saline (40 ml) will be administered before chemotherapy in patients assigned to the control group.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Paclitaxel, carboplatin and bevacizumab
Intervention Description
Paclitaxel (175mg/m2), carboplatin (AUC 5.0 or 6.0) IV, and bevacizumab IV (15mg/kg) D1, every three weeks.
Primary Outcome Measure Information:
Title
Incidence of chemotherapy-induced peripheral neuropathy (3m)
Description
To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.
Time Frame
Examined at 3 months after last paclitaxel chemotherapy
Secondary Outcome Measure Information:
Title
Incidence of chemotherapy-induced peripheral neuropathy (baseline, 3wk)
Description
To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.
Time Frame
Examined on the day 0 of first chemotherapy, 3 weeks after last paclitaxel chemotherapy, and checked before start of every chemotherapy cycles (each cycle is 21 days)
Title
Severity of chemotherapy-induced peripheral neuropathy
Description
To evaluate the severity of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.
Time Frame
Examined on the day 0 of first chemotherapy, 3 weeks after last paclitaxel chemotherapy, 3 months after last paclitaxel chemotherapy, and checked before start of every chemotherapy cycles (each cycle is 21 days)
Title
Assessment of quality of life1
Description
Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale: 30-126, the higher score means better quality of life
Time Frame
Examined on the day 0 of first chemotherapy, 3 weeks after completion of 3 cycles of chemotherapy, 3 weeks after completion of 6 cycles of chemotherapy, and 3 months after completion of 6 cycles of chemotherapy (each cycle is 21 days)
Title
Assessment of quality of life2
Description
Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Chemotherapy Induced Peripheral Neuropathy 20 (EORTC-CIPN20) Scale: 20-80, the higher score mean worse symptom
Time Frame
Examined on the day 0 of first chemotherapy, 3 weeks after completion of 3 cycles of chemotherapy, 3 weeks after completion of 6 cycles of chemotherapy, and 3 months after completion of 6 cycles of chemotherapy (each cycle is 21 days)
Title
concomitant medication1
Description
Dosage and usage of concomitant medication (neurontin) for CIPN
Time Frame
Checked on the day 0 of every cycles of chemotherapy, 3 weeks after completion of 3 cycles of chemotherapy, 3 weeks after completion of 6 cycles of chemotherapy, and 3 months after completion of 6 cycles of chemotherapy (each cycle is 21 days)
Title
concomitant medication2
Description
Dosage and usage of concomitant medication (duloxetine) for CIPN
Time Frame
Checked on the day 0 of every cycles of chemotherapy (each cycle is 21 days), from day 1 to day 21 on each cycle
Title
concomitant medication3
Description
Dosage and usage of concomitant medication (celecoxib) for CIPN
Time Frame
Checked on the day 0 of every cycles of chemotherapy, 3 weeks after completion of 3 cycles of chemotherapy, 3 weeks after completion of 6 cycles of chemotherapy, and 3 months after completion of 6 cycles of chemotherapy (each cycle is 21 days)
Title
Adverse events 1
Description
Evaluation of chemotherapy-induced toxicity hematologic (ANC, Hb, Plt) and non-hematologic (nausea, vomiting, diarrhea, constipation, hypersensitivity reaction) symptoms are evaluated by Common Terminology Criteria for Adverse Events ver 5.0 by grade
Time Frame
From the day 1 of chemotherapy to the day before starting next cycle (each cycle is 21 days), 3 weeks after completion of 3 cycles of chemotherapy, 3 weeks after completion of 6 cycles of chemotherapy, and 3 months after completion of 6 cycle
Title
Adverse events 2
Description
Evaluation of any toxicity related to intravenous selenium administration (garlic odor, nausea, vomiting, hypersensitivity reaction) symptoms are evaluated by Common Terminology Criteria for Adverse Events ver 5.0 by grade
Time Frame
From the date of first day of chemotherapy to the day before starting next cycle (each cycle is 21 days), 3 weeks after completion of 3 cycles of chemotherapy, 3 weeks after completion of 6 cycles of chemotherapy, and 3 months after completion of 6 cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent Age: 19-80 years old 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. Patients who have received paclitaxel chemotherapy for a minimum of 6 cycles and a maximum of 9 cycles Eastern Cooperative Oncology Group performance status 0-2 Patients with no other concurrent disease affecting overall survival Patients with normal hematologic, renal, and liver functions Patients who understand the contents of the clinical trial and are capable of participating until the end of the trial Exclusion Criteria: Pregnancy or breastfeeding Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who received secondary debulking surgery. Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who did not receive Bevacizumab chemotherapy Patients with other concurrent disease that can affect overall survival (infection, hypertension, diabetes, cardiac disease, etcetera) Patients with underlying disease (diabetes, neuropathy, brain or bone metastasis) that can induced neuropathy Patients allergic to selenium Inappropriate patients by the researcher's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD/PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy

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