Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-04 @ 5:21 PM
Study NCT ID:
NCT03495492
Status:
UNKNOWN
Last Update Posted:
2018-04-12
First Post:
2018-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Lymphocytic Leukemia Responds to Dermal Chelation
Sponsor:
Organization:
Raw JSON
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Tobacco smoke exposure and levels of urinary metals in the U.S. youth and adult population: the National Health and Nutrition Examination Survey (NHANES) 1999-2004. Int J Environ Res Public Health. 2009 Jul;6(7):1930-46. doi: 10.3390/ijerph6071930. Epub 2009 Jul 2.'}, {'pmid': '9630463', 'type': 'RESULT', 'citation': 'Sandborgh-Englund G, Elinder CG, Johanson G, Lind B, Skare I, Ekstrand J. The absorption, blood levels, and excretion of mercury after a single dose of mercury vapor in humans. Toxicol Appl Pharmacol. 1998 May;150(1):146-53. doi: 10.1006/taap.1998.8400.'}, {'pmid': '22293416', 'type': 'RESULT', 'citation': 'Yaginuma-Sakurai K, Murata K, Iwai-Shimada M, Nakai K, Kurokawa N, Tatsuta N, Satoh H. Hair-to-blood ratio and biological half-life of mercury: experimental study of methylmercury exposure through fish consumption in humans. J Toxicol Sci. 2012 Feb;37(1):123-30. doi: 10.2131/jts.37.123.'}, {'pmid': '22945569', 'type': 'RESULT', 'citation': 'Tchounwou PB, Yedjou CG, Patlolla AK, Sutton DJ. Heavy metal toxicity and the environment. Exp Suppl. 2012;101:133-64. doi: 10.1007/978-3-7643-8340-4_6.'}, {'pmid': '1131339', 'type': 'RESULT', 'citation': 'Barry PS. A comparison of concentrations of lead in human tissues. Br J Ind Med. 1975 May;32(2):119-39. doi: 10.1136/oem.32.2.119.'}, {'pmid': '11333192', 'type': 'RESULT', 'citation': 'Vaglenov A, Creus A, Laltchev S, Petkova V, Pavlova S, Marcos R. Occupational exposure to lead and induction of genetic damage. Environ Health Perspect. 2001 Mar;109(3):295-8. doi: 10.1289/ehp.01109295.'}, {'pmid': '27486361', 'type': 'RESULT', 'citation': 'Wani AL, Ara A, Usmani JA. Lead toxicity: a review. Interdiscip Toxicol. 2015 Jun;8(2):55-64. doi: 10.1515/intox-2015-0009.'}, {'pmid': '21827276', 'type': 'RESULT', 'citation': 'Nie LH, Wright RO, Bellinger DC, Hussain J, Amarasiriwardena C, Chettle DR, Pejovic-Milic A, Woolf A, Shannon M. Blood lead levels and cumulative blood lead index (CBLI) as predictors of late neurodevelopment in lead poisoned children. Biomarkers. 2011 Sep;16(6):517-24. doi: 10.3109/1354750X.2011.604133. Epub 2011 Aug 9.'}, {'pmid': '26264017', 'type': 'RESULT', 'citation': 'Jo S, Woo HD, Kwon HJ, Oh SY, Park JD, Hong YS, Pyo H, Park KS, Ha M, Kim H, Sohn SJ, Kim YM, Lim JA, Lee SA, Eom SY, Kim BG, Lee KM, Lee JH, Hwang MS, Kim J. Estimation of the Biological Half-Life of Methylmercury Using a Population Toxicokinetic Model. Int J Environ Res Public Health. 2015 Jul 31;12(8):9054-67. doi: 10.3390/ijerph120809054.'}, {'pmid': '24368178', 'type': 'RESULT', 'citation': 'Rooney JP. The retention time of inorganic mercury in the brain--a systematic review of the evidence. Toxicol Appl Pharmacol. 2014 Feb 1;274(3):425-35. doi: 10.1016/j.taap.2013.12.011. Epub 2013 Dec 22.'}, {'pmid': '19897186', 'type': 'RESULT', 'citation': 'Cretacci Y, Parsons PJ. Localized accumulation of lead within and among bones from lead-dosed goats. Environ Res. 2010 Jan;110(1):26-32. doi: 10.1016/j.envres.2009.09.005.'}, {'pmid': '3149183', 'type': 'RESULT', 'citation': 'Flood PR, Schmidt PF, Wesenberg GR, Gadeholt H. The distribution of lead in human hemopoietic tissue and spongy bone after lead poisoning and Ca-EDTA chelation therapy. Observations made by atomic absorption spectroscopy, laser microbeam mass analysis and electron microbeam X-ray analysis. Arch Toxicol. 1988;62(4):295-300. doi: 10.1007/BF00332490.'}, {'pmid': '6363310', 'type': 'RESULT', 'citation': 'Stelzer KJ, Pazdernik TL. Cadmium-induced immunotoxicity. Int J Immunopharmacol. 1983;5(6):541-8. doi: 10.1016/0192-0561(83)90047-4.'}, {'pmid': '1250252', 'type': 'RESULT', 'citation': 'Bauchinger M, Schmid E, Einbrodt HJ, Dresp J. Chromosome aberrations in lymphocytes after occupational exposure to lead and cadmium. Mutat Res. 1976 Jan;40(1):57-62. doi: 10.1016/0165-1218(76)90023-9. No abstract available.'}, {'pmid': '15689032', 'type': 'RESULT', 'citation': 'Grujic S, Ristic M, Lausevic M. Heavy metals in petroleum-contaminated surface soils in Serbia. Ann Chim. 2004 Dec;94(12):961-70. doi: 10.1002/adic.200490118.'}, {'pmid': '15092991', 'type': 'RESULT', 'citation': 'Stigter JB, de Haan HP, Guicherit R, Dekkers CP, Daane ML. Determination of cadmium, zinc, copper, chromium and arsenic in crude oil cargoes. Environ Pollut. 2000 Mar;107(3):451-64. doi: 10.1016/s0269-7491(99)00123-2.'}, {'pmid': '4513535', 'type': 'RESULT', 'citation': 'Cline DM, Hiott DW, Nunnery KE, Shealy RG, Towles WC, Watkins RW. Pneumatosis cystoides intestinalis. J S C Med Assoc. 1973 Jun;69(6):226-8. No abstract available.'}, {'pmid': '2738890', 'type': 'RESULT', 'citation': 'Kang Y, Larson SB, Robins RK, Revankar GR. Synthesis and biological evaluation of certain 3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-b)pyridazines related to formycin prepared via ring closure of pyridazine precursors. J Med Chem. 1989 Jul;32(7):1547-51. doi: 10.1021/jm00127a024.'}, {'pmid': '1009120', 'type': 'RESULT', 'citation': 'Farooqui AA, Roy AB. The sulphatase of ox liver. XX. The preparation of sulphatases B1alpha and B1beta. Biochim Biophys Acta. 1976 Dec 8;452(2):431-9. doi: 10.1016/0005-2744(76)90193-5.'}, {'pmid': '25445091', 'type': 'RESULT', 'citation': 'Van Neste D. Why care about linear hair growth rates (LHGR)? a study using in vivo imaging and computer assisted image analysis after manual processing (CAIAMP) in unaffected male controls and men with male pattern hair loss (MPHL). Eur J Dermatol. 2014 Sep-Oct;24(5):568-76. doi: 10.1684/ejd.2014.2428.'}, {'pmid': '14965792', 'type': 'RESULT', 'citation': 'Van Neste D. Thickness, medullation and growth rate of female scalp hair are subject to significant variation according to pigmentation and scalp location during ageing. Eur J Dermatol. 2004 Jan-Feb;14(1):28-32.'}, {'pmid': '25009099', 'type': 'RESULT', 'citation': 'Li J, Cen D, Huang D, Li X, Xu J, Fu S, Cai R, Wu X, Tang M, Sun Y, Zhang J, Zheng J. Detection and analysis of 12 heavy metals in blood and hair sample from a general population of Pearl River Delta area. Cell Biochem Biophys. 2014 Dec;70(3):1663-9. doi: 10.1007/s12013-014-0110-6.'}, {'pmid': '4609793', 'type': 'RESULT', 'citation': "Vorob'ev VI, Kosjuk GN. Distribution of repetitive and non-repetitive nucleotide sequences in the DNA of sea urchin. FEBS Lett. 1974 Oct 1;47(1):43-6. doi: 10.1016/0014-5793(74)80422-9. No abstract available."}, {'pmid': '1719661', 'type': 'RESULT', 'citation': 'McCabe MJ Jr, Lawrence DA. Lead, a major environmental pollutant, is immunomodulatory by its differential effects on CD4+ T cells subsets. Toxicol Appl Pharmacol. 1991 Oct;111(1):13-23. doi: 10.1016/0041-008x(91)90129-3.'}, {'pmid': '10771143', 'type': 'RESULT', 'citation': 'Devi KD, Banu BS, Grover P, Jamil K. Genotoxic effect of lead nitrate on mice using SCGE (comet assay). Toxicology. 2000 Apr 14;145(2-3):195-201. doi: 10.1016/s0300-483x(00)00154-2.'}, {'pmid': '22235210', 'type': 'RESULT', 'citation': 'Bernhoft RA. Mercury toxicity and treatment: a review of the literature. J Environ Public Health. 2012;2012:460508. doi: 10.1155/2012/460508. Epub 2011 Dec 22.'}, {'pmid': '1068773', 'type': 'RESULT', 'citation': 'Rose TP. Sterilization of carious dentine with silver nitrate. Chronicle. 1976 Oct;39(8):151, 159. No abstract available.'}, {'pmid': '7023931', 'type': 'RESULT', 'citation': 'Vainio H, Sorsa M. Chromosome aberrations and their relevance to metal carcinogenesis. Environ Health Perspect. 1981 Aug;40:173-80. doi: 10.1289/ehp.8140173.'}, {'pmid': '11703167', 'type': 'RESULT', 'citation': 'Bass DA, Hickock D, Quig D, Urek K. Trace element analysis in hair: factors determining accuracy, precision, and reliability. Altern Med Rev. 2001 Oct;6(5):472-81.'}, {'pmid': '6824602', 'type': 'RESULT', 'citation': 'Niculescu T, Dumitru R, Botha V, Alexandrescu R, Manolescu N. Relationship between the lead concentration in hair and occupational exposure. Br J Ind Med. 1983 Feb;40(1):67-70. doi: 10.1136/oem.40.1.67.'}, {'pmid': '26508811', 'type': 'RESULT', 'citation': 'Mohamed Fel B, Zaky EA, El-Sayed AB, Elhossieny RM, Zahra SS, Salah Eldin W, Youssef WY, Khaled RA, Youssef AM. Assessment of Hair Aluminum, Lead, and Mercury in a Sample of Autistic Egyptian Children: Environmental Risk Factors of Heavy Metals in Autism. Behav Neurol. 2015;2015:545674. doi: 10.1155/2015/545674. Epub 2015 Oct 5.'}, {'pmid': '26185180', 'type': 'RESULT', 'citation': 'Jung SY, Kim S, Lee K, Kim JY, Bae WK, Lee K, Han JS, Kim S. Association between secondhand smoke exposure and blood lead and cadmium concentration in community dwelling women: the fifth Korea National Health and Nutrition Examination Survey (2010-2012). BMJ Open. 2015 Jul 16;5(7):e008218. doi: 10.1136/bmjopen-2015-008218.'}, {'pmid': '21540277', 'type': 'RESULT', 'citation': 'Horiguchi H, Oguma E, Kayama F. Cadmium induces anemia through interdependent progress of hemolysis, body iron accumulation, and insufficient erythropoietin production in rats. Toxicol Sci. 2011 Jul;122(1):198-210. doi: 10.1093/toxsci/kfr100. Epub 2011 May 3.'}], 'seeAlsoLinks': [{'url': 'https://booksite.elsevier.com/samplechapters/9780123694133/Sample_Chapters/01~Front_Matter.pdf', 'label': 'Mercury section in Chapter 33'}, {'url': 'https://www.niehs.nih.gov/health/topics/agents/mercury/index.cfm', 'label': 'National Institute of Environmental Health Science Information on Mercury'}, {'url': 'https://www.mayoclinic.org/diseases-conditions/enlarged-spleen/symptoms-causes/syc-20354326', 'label': 'Mayo Clinic. "Enlarged spleen (splenomegaly)." Mayo Foundation for Medical Education and Research (MFMER) 1998-2017.'}, {'url': 'http://www.merckmanuals.com/home/blood-disorders/spleen-disorders/overview-of-the-spleen', 'label': 'Jacob, Harry S. "Overview of the spleen." Merck Manual. Last full review/revision November 2016'}, {'url': 'https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/what-is-all.html', 'label': 'American Cancer Society. What Is Acute Lymphocytic Leukemia? The American Cancer Society medical and editorial content team. Last Medical Review: December 2, 2014 Last Revised: February 18, 2016.'}, {'url': 'https://www.ncbi.nlm.nih.gov/books/NBK261/', 'label': 'Chapter 153, The White Blood Cell and Differential Count'}, {'url': 'https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/key-statistics.html', 'label': 'Key Statistics for Chronic Lymphocytic Leukemia'}, {'url': 'https://www.mayoclinic.org/diseases-conditions/leukemia/symptoms-causes/syc-20374373', 'label': "Mayo Clinic's Information on Leukemia"}, {'url': 'https://www.mayoclinic.org/diseases-conditions/chronic-lymphocytic-leukemia/diagnosis-treatment/drc-20352433', 'label': "Mayo Clinic's Information on Chronic Lymphocytic Leukemia"}, {'url': 'https://www.hopkinsmedicine.org/kimmel_cancer_center/centers/leukemia_program/current_treatments.html', 'label': 'Johns Hopkins Medicine. Leukemia Treatments. The Sidney Kimmel Comprehensive Cancer Center'}, {'url': 'https://www.omicsonline.org/liver-and-cadmium-toxicity-2157-7609.S5-001.php?aid=3686', 'label': 'Liver and Cadmium Toxicity. J Drug Metabol Toxicology'}, {'url': 'http://nj.gov/health/eoh/rtkweb/documents/fs/1349.pdf', 'label': 'New Jersey Department of Health. Right to Know Hazardous Substance Fact Sheet. Revision 4/2010'}, {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20714_NICOTROL%20INHALER%2010MG,%20CARTRIDE_EAFONSI.PDF', 'label': 'Center for Drug Evaluation and Research. Environmental Assessment and Finding of no Significant Impact of Nicotine Inhaler (Nicotine Inhalation System). Food and Drug Administration. Date completed: 3/5/1977.'}, {'url': 'http://journals.sagepub.com/doi/abs/10.1191/0960327104ht472oa?journalCode=hetb', 'label': 'American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. The American Cancer Society medical and editorial content team. Last Medical Review: January 6, 2015 Last Revised: January 4, 2018'}, {'url': 'https://seer.cancer.gov/statfacts/html/leuks.html', 'label': 'National Cancer Institute. Cancer Stat Facts: Leukemia. Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. SEER Data, 1973-2014.'}, {'url': 'https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq#section/_30', 'label': 'National Cancer Institute at the National Institutes of Health. Chronic Lymphocytic Leukemia Treatment. Updated: October 26, 2017.'}, {'url': 'https://www.hopkinsmedicine.org/kimmel_cancer_center/centers/leukemia_program/current_treatments.html', 'label': 'Johns Hopkins Medicine. Leukemia Treatments. The Sidney Kimmel Comprehensive Cancer Center 1973-'}, {'url': 'https://www.mayoclinic.org/diseases-conditions/chronic-lymphocytic-leukemia/diagnosis-treatment/drc-20352433', 'label': 'Mayo Clinic. Chronic lymphocytic leukemia. Blood Test Information'}, {'url': 'https://www.cancer.net/cancer-types/leukemia-chronic-lymphocytic-cll/statistics', 'label': 'American Society of Clinical Oncology (ASCO). Leukemia - Chronic Lymphocytic - CLL: Statistics. Approved by the Cancer.Net Editorial Board, 06/2016'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to identify 50 participants with Chronic Lymphocytic Leukemia (CLL) and follow their total white blood cell (WBC) counts and absolute lymphocyte counts after performing dermal chelation and administering nutritional therapy', 'detailedDescription': 'The purpose of this clinical trial is to use dermal chelation and hair tissue analysis to identify 50 participants with CLL. The total wbc counts and absolute lymphocyte counts of these participants will be followed after serial dermal chelations and nutritional therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Chronic Lymphocytic Leukemia and has a toxic heavy metal load\n* Toxic heavy metal load\n\nExclusion Criteria:\n\n* Pregnant\n* Pacemaker implants\n* Organ transplant recipients\n* Psychotic episodes or epileptic seizures'}, 'identificationModule': {'nctId': 'NCT03495492', 'briefTitle': 'Chronic Lymphocytic Leukemia Responds to Dermal Chelation', 'organization': {'class': 'OTHER', 'fullName': 'Optimum Health, Natural Healthcare Center'}, 'officialTitle': 'Dermal Chelation Lowers White Blood Cell Count in Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'DCCLL2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'description': 'Group receiving dermal chelation and nutritional therapy', 'interventionNames': ['Device: Dermal Chelation', 'Dietary Supplement: Nutritional Therapy']}], 'interventions': [{'name': 'Dermal Chelation', 'type': 'DEVICE', 'description': 'Dermal chelation with Aqua DetoxTM system for one or more hours one or more times each week.', 'armGroupLabels': ['Participants']}, {'name': 'Nutritional Therapy', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamins and minerals that will be taken one or more times a day.', 'armGroupLabels': ['Participants']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimum Health, Natural Healthcare Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}