High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy
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- STATUS
- Recruiting
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- End date
- Dec 31, 2024
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- participants needed
- 68
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- sponsor
- Seoul National University Hospital
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 Identifier | NCT04201561 |
| Sponsor | Seoul National University Hospital |
| Last Modified on | 24 January 2021 |
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