Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-28 @ 11:10 PM
Study NCT ID:
NCT04201561
Status:
UNKNOWN
Last Update Posted:
2023-06-26
First Post:
2019-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018038', 'term': 'Sodium Selenite'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D020887', 'term': 'Selenious Acid'}, {'id': 'D018036', 'term': 'Selenium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2019-12-08', 'studyFirstSubmitQcDate': '2019-12-15', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chemotherapy-induced peripheral neuropathy (3m)', 'timeFrame': 'Examined at 3 months after last paclitaxel chemotherapy', 'description': 'To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.'}], 'secondaryOutcomes': [{'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)', 'description': 'To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.'}, {'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)', 'description': 'To evaluate the severity of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.'}, {'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)', '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'}, {'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)', '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'}, {'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)', 'description': 'Dosage and usage of concomitant medication (neurontin) for CIPN'}, {'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', 'description': 'Dosage and usage of concomitant medication (duloxetine) for CIPN'}, {'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)', 'description': 'Dosage and usage of concomitant medication (celecoxib) for CIPN'}, {'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', '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'}, {'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', '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peripheral neuropathy', 'recurrent ovarian cancer', 'high-dose inorganic selenium', 'sodium selenite'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy', 'Recurrent Ovarian Carcinoma', 'Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '27531571', 'type': 'BACKGROUND', 'citation': 'Hay CM, Courtney-Brooks M, Lefkowits C, Hagan TL, Edwards RP, Donovan HS. Symptom management in women with recurrent ovarian cancer: Do patients and clinicians agree on what symptoms are most important? Gynecol Oncol. 2016 Nov;143(2):367-370. doi: 10.1016/j.ygyno.2016.08.235. Epub 2016 Aug 13.'}, {'pmid': '16473643', 'type': 'BACKGROUND', 'citation': 'Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F. Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol. 2006 Feb;33(1):15-49. doi: 10.1053/j.seminoncol.2005.12.010.'}, {'pmid': '29117336', 'type': 'BACKGROUND', 'citation': 'Park SB, Kwok JB, Asher R, Lee CK, Beale P, Selle F, Friedlander M. Clinical and genetic predictors of paclitaxel neurotoxicity based on patient- versus clinician-reported incidence and severity of neurotoxicity in the ICON7 trial. Ann Oncol. 2017 Nov 1;28(11):2733-2740. doi: 10.1093/annonc/mdx491.'}, {'pmid': '24789421', 'type': 'BACKGROUND', 'citation': 'Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014 Aug;22(8):2261-9. doi: 10.1007/s00520-014-2255-7. Epub 2014 May 1.'}, {'pmid': '30736741', 'type': 'BACKGROUND', 'citation': 'Molassiotis A, Cheng HL, Lopez V, Au JSK, Chan A, Bandla A, Leung KT, Li YC, Wong KH, Suen LKP, Chan CW, Yorke J, Farrell C, Sundar R. Are we mis-estimating chemotherapy-induced peripheral neuropathy? Analysis of assessment methodologies from a prospective, multinational, longitudinal cohort study of patients receiving neurotoxic chemotherapy. BMC Cancer. 2019 Feb 8;19(1):132. doi: 10.1186/s12885-019-5302-4.'}, {'pmid': '25459280', 'type': 'BACKGROUND', 'citation': 'Carozzi VA, Canta A, Chiorazzi A. Chemotherapy-induced peripheral neuropathy: What do we know about mechanisms? Neurosci Lett. 2015 Jun 2;596:90-107. doi: 10.1016/j.neulet.2014.10.014. Epub 2014 Oct 22.'}, {'pmid': '27393249', 'type': 'BACKGROUND', 'citation': 'Duggett NA, Griffiths LA, McKenna OE, de Santis V, Yongsanguanchai N, Mokori EB, Flatters SJ. Oxidative stress in the development, maintenance and resolution of paclitaxel-induced painful neuropathy. Neuroscience. 2016 Oct 1;333:13-26. doi: 10.1016/j.neuroscience.2016.06.050. Epub 2016 Jul 5.'}, {'pmid': '24751598', 'type': 'BACKGROUND', 'citation': 'Erken HA, Koc ER, Yazici H, Yay A, Onder GO, Sarici SF. Selenium partially prevents cisplatin-induced neurotoxicity: a preliminary study. Neurotoxicology. 2014 May;42:71-5. doi: 10.1016/j.neuro.2014.04.002. Epub 2014 Apr 19.'}, {'pmid': '15642899', 'type': 'BACKGROUND', 'citation': 'Argyriou AA, Chroni E, Koutras A, Ellul J, Papapetropoulos S, Katsoulas G, Iconomou G, Kalofonos HP. Vitamin E for prophylaxis against chemotherapy-induced neuropathy: a randomized controlled trial. Neurology. 2005 Jan 11;64(1):26-31. doi: 10.1212/01.WNL.0000148609.35718.7D.'}, {'pmid': '16939848', 'type': 'BACKGROUND', 'citation': 'Argyriou AA, Chroni E, Koutras A, Iconomou G, Papapetropoulos S, Polychronopoulos P, Kalofonos HP. Preventing paclitaxel-induced peripheral neuropathy: a phase II trial of vitamin E supplementation. J Pain Symptom Manage. 2006 Sep;32(3):237-44. doi: 10.1016/j.jpainsymman.2006.03.013.'}, {'pmid': '22894640', 'type': 'BACKGROUND', 'citation': 'Ghoreishi Z, Esfahani A, Djazayeri A, Djalali M, Golestan B, Ayromlou H, Hashemzade S, Asghari Jafarabadi M, Montazeri V, Keshavarz SA, Darabi M. Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: a randomized double-blind placebo controlled trial. BMC Cancer. 2012 Aug 15;12:355. doi: 10.1186/1471-2407-12-355.'}, {'pmid': '34132071', 'type': 'DERIVED', 'citation': 'Park SJ, Yim GW, Paik H, Lee N, Lee S, Lee M, Kim HS. Efficacy and safety of intravenous administration of high-dose selenium for preventing chemotherapy-induced peripheral neuropathy in platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer: study protocol for a phase III, double-blind, randomized study. J Gynecol Oncol. 2021 Sep;32(5):e73. doi: 10.3802/jgo.2021.32.e73. Epub 2021 Jun 1.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent\n2. Age: 19-80 years old\n3. 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.\n4. Patients who have received paclitaxel chemotherapy for a minimum of 6 cycles and a maximum of 9 cycles\n5. Eastern Cooperative Oncology Group performance status 0-2\n6. Patients with no other concurrent disease affecting overall survival\n7. Patients with normal hematologic, renal, and liver functions\n8. Patients who understand the contents of the clinical trial and are capable of participating until the end of the trial\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding\n2. Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who received secondary debulking surgery.\n3. Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who did not receive Bevacizumab chemotherapy\n4. Patients with other concurrent disease that can affect overall survival (infection, hypertension, diabetes, cardiac disease, etcetera)\n5. Patients with underlying disease (diabetes, neuropathy, brain or bone metastasis) that can induced neuropathy\n6. Patients allergic to selenium\n7. Inappropriate patients by the researcher's decision"}, 'identificationModule': {'nctId': 'NCT04201561', 'acronym': 'SELENIUM', 'briefTitle': 'High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SELENIUM trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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.', 'interventionNames': ['Drug: sodium selenite pentahydrate', 'Drug: Chemotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', '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.', 'interventionNames': ['Drug: Normal saline', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'sodium selenite pentahydrate', 'type': 'DRUG', 'otherNames': ['Selentab inj. A12CE02'], 'description': 'High-dose inorganic selenium (2000 μg/40 ml) will be administered before chemotherapy in patients assigned to the experimental group.', 'armGroupLabels': ['Experimental group']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['sodium chloride 0.9%'], 'description': 'Normal saline (40 ml) will be administered before chemotherapy in patients assigned to the control group.', 'armGroupLabels': ['Placebo group']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['Paclitaxel, carboplatin and bevacizumab'], 'description': 'Paclitaxel (175mg/m2), carboplatin (AUC 5.0 or 6.0) IV, and bevacizumab IV (15mg/kg) D1, every three weeks.', 'armGroupLabels': ['Experimental group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hee Seung Kim, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hee Seung Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}