Clinical trial NCT04201561: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2019-12-17
Enrollment: 68
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of chemotherapy-induced peripheral neuropathy (3m)
timeFrame: Examined at 3 months after last paclitaxel chemotherapy
Secondary outcomes:
measure: Incidence of chemotherapy-induced peripheral neuropathy (baseline, 3wk)
timeFrame: 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)
measure: Severity of chemotherapy-induced peripheral neuropathy
timeFrame: 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)
measure: Assessment of quality of life1
timeFrame: 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)
measure: Assessment of quality of life2
timeFrame: 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)
measure: concomitant medication1
timeFrame: 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)
measure: concomitant medication2
timeFrame: Checked on the day 0 of every cycles of chemotherapy (each cycle is 21 days), from day 1 to day 21 on each cycle
measure: concomitant medication3
timeFrame: 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)
measure: Adverse events 1
timeFrame: 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
measure: Adverse events 2
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
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