High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    68
  • sponsor
    Seoul National University Hospital
Updated on 24 January 2021
paclitaxel
cancer
carboplatin
bevacizumab
neuropathy
cancer chemotherapy
solid tumour
ovarian cancer
gynecologic cancer
ovarian epithelial cancer
peripheral neuropathy
primary peritoneal cancer
selenium
peritoneal cancer
primary peritoneal carcinoma
ovarian epithelial carcinoma
cancer of the ovary

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.

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.

Details
Condition Ovarian disorder, Ovarian Function, Fallopian Tube Cancer, Fallopian Tube Cancer, Ovarian Cancer, Ovarian Cancer, Recurrent Ovarian Cancer, Ovarian Function, Primary Peritoneal Cancer, Recurrent Ovarian Carcinoma, Primary Peritoneal Carcinoma, Recurrent Ovarian Cancer, Chemotherapy Induced Peripheral Neuropathy, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, fallopian tube cancers, ovarian tumors
Treatment Normal saline, Chemotherapy, sodium selenite pentahydrate, sodium selenite pentahydrate
Clinical Study IdentifierNCT04201561
SponsorSeoul National University Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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