search
Back to results

Chronic Lymphocytic Leukemia Responds to Dermal Chelation

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dermal Chelation
Nutritional Therapy
Sponsored by
Optimum Health, Natural Healthcare Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, CLL, Dermal Chelation, Nutritional Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Chronic Lymphocytic Leukemia and has a toxic heavy metal load
  • Toxic heavy metal load

Exclusion Criteria:

  • Pregnant
  • Pacemaker implants
  • Organ transplant recipients
  • Psychotic episodes or epileptic seizures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants

    Arm Description

    Group receiving dermal chelation and nutritional therapy

    Outcomes

    Primary Outcome Measures

    Serial Total White Blood Cell Count
    Total WBC counts taken on a regular interval.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2018
    Last Updated
    April 4, 2018
    Sponsor
    Optimum Health, Natural Healthcare Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03495492
    Brief Title
    Chronic Lymphocytic Leukemia Responds to Dermal Chelation
    Official Title
    Dermal Chelation Lowers White Blood Cell Count in Chronic Lymphocytic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2018 (Anticipated)
    Primary Completion Date
    March 1, 2019 (Anticipated)
    Study Completion Date
    March 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Optimum Health, Natural Healthcare Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Lymphocytic Leukemia
    Keywords
    Chronic Lymphocytic Leukemia, CLL, Dermal Chelation, Nutritional Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Clinical trials with a single arm
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants
    Arm Type
    Experimental
    Arm Description
    Group receiving dermal chelation and nutritional therapy
    Intervention Type
    Device
    Intervention Name(s)
    Dermal Chelation
    Intervention Description
    Dermal chelation with Aqua DetoxTM system for one or more hours one or more times each week.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutritional Therapy
    Intervention Description
    Vitamins and minerals that will be taken one or more times a day.
    Primary Outcome Measure Information:
    Title
    Serial Total White Blood Cell Count
    Description
    Total WBC counts taken on a regular interval.
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Chronic Lymphocytic Leukemia and has a toxic heavy metal load Toxic heavy metal load Exclusion Criteria: Pregnant Pacemaker implants Organ transplant recipients Psychotic episodes or epileptic seizures

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    19742163
    Citation
    Richter PA, Bishop EE, Wang J, Swahn MH. 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.
    Results Reference
    background
    PubMed Identifier
    9630463
    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.
    Results Reference
    result
    PubMed Identifier
    22293416
    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.
    Results Reference
    result
    PubMed Identifier
    22945569
    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.
    Results Reference
    result
    PubMed Identifier
    1131339
    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.
    Results Reference
    result
    PubMed Identifier
    11333192
    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.
    Results Reference
    result
    PubMed Identifier
    27486361
    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.
    Results Reference
    result
    PubMed Identifier
    21827276
    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.
    Results Reference
    result
    PubMed Identifier
    26264017
    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.
    Results Reference
    result
    PubMed Identifier
    24368178
    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.
    Results Reference
    result
    PubMed Identifier
    19897186
    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.
    Results Reference
    result
    PubMed Identifier
    3149183
    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.
    Results Reference
    result
    PubMed Identifier
    6363310
    Citation
    Stelzer KJ, Pazdernik TL. Cadmium-induced immunotoxicity. Int J Immunopharmacol. 1983;5(6):541-8. doi: 10.1016/0192-0561(83)90047-4.
    Results Reference
    result
    PubMed Identifier
    1250252
    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.
    Results Reference
    result
    PubMed Identifier
    15689032
    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.
    Results Reference
    result
    PubMed Identifier
    15092991
    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.
    Results Reference
    result
    PubMed Identifier
    4513535
    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.
    Results Reference
    result
    PubMed Identifier
    2738890
    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.
    Results Reference
    result
    PubMed Identifier
    1009120
    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.
    Results Reference
    result
    PubMed Identifier
    25445091
    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.
    Results Reference
    result
    PubMed Identifier
    14965792
    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.
    Results Reference
    result
    PubMed Identifier
    25009099
    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.
    Results Reference
    result
    PubMed Identifier
    4609793
    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.
    Results Reference
    result
    PubMed Identifier
    1719661
    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.
    Results Reference
    result
    PubMed Identifier
    10771143
    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.
    Results Reference
    result
    PubMed Identifier
    22235210
    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.
    Results Reference
    result
    PubMed Identifier
    1068773
    Citation
    Rose TP. Sterilization of carious dentine with silver nitrate. Chronicle. 1976 Oct;39(8):151, 159. No abstract available.
    Results Reference
    result
    PubMed Identifier
    7023931
    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.
    Results Reference
    result
    PubMed Identifier
    11703167
    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.
    Results Reference
    result
    PubMed Identifier
    6824602
    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.
    Results Reference
    result
    PubMed Identifier
    26508811
    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.
    Results Reference
    result
    PubMed Identifier
    26185180
    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.
    Results Reference
    result
    PubMed Identifier
    21540277
    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.
    Results Reference
    result
    Links:
    URL
    https://www.atsdr.cdc.gov/phs/phs.asp?id=92&tid=22
    Description
    Agency for Toxic Substances and Disease Registry (ATSDR). Toxic Substances Portal - Lead. Public Health Statement for Lead August 2007
    URL
    https://www.atsdr.cdc.gov/csem/csem.asp?csem=6&po=9
    Description
    Agency for Toxic Substances and Disease Registry (ATSDR). Cadmium Toxicity What Is the Biological Fate of Cadmium in the Body? Environmental Health and Medicine Education 2008-2013
    URL
    https://booksite.elsevier.com/samplechapters/9780123694133/Sample_Chapters/01~Front_Matter.pdf
    Description
    Mercury section in Chapter 33
    URL
    https://link.springer.com/article/10.1186/2050-7445-1-10
    Description
    The distribution of mercury and other trace elements in the bones of two human individuals from medieval Denmark - the chemical life history hypothesis
    URL
    https://www.niehs.nih.gov/health/topics/agents/mercury/index.cfm
    Description
    National Institute of Environmental Health Science Information on Mercury
    URL
    https://www.mayoclinic.org/diseases-conditions/enlarged-spleen/symptoms-causes/syc-20354326
    Description
    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
    Description
    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
    Description
    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/
    Description
    Chapter 153, The White Blood Cell and Differential Count
    URL
    https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/key-statistics.html
    Description
    Key Statistics for Chronic Lymphocytic Leukemia
    URL
    https://www.mayoclinic.org/diseases-conditions/leukemia/symptoms-causes/syc-20374373
    Description
    Mayo Clinic's Information on Leukemia
    URL
    https://www.mayoclinic.org/diseases-conditions/chronic-lymphocytic-leukemia/diagnosis-treatment/drc-20352433
    Description
    Mayo Clinic's Information on Chronic Lymphocytic Leukemia
    URL
    https://www.hopkinsmedicine.org/kimmel_cancer_center/centers/leukemia_program/current_treatments.html
    Description
    Johns Hopkins Medicine. Leukemia Treatments. The Sidney Kimmel Comprehensive Cancer Center
    URL
    https://www.hindawi.com/journals/jeph/2012/258968/
    Description
    Objective Assessment of an Ionic Footbath (IonCleanse): Testing Its Ability to Remove Potentially Toxic Elements from the Body
    URL
    https://www.omicsonline.org/liver-and-cadmium-toxicity-2157-7609.S5-001.php?aid=3686
    Description
    Liver and Cadmium Toxicity. J Drug Metabol Toxicology
    URL
    https://www.atsdr.cdc.gov/phs/phs.asp?id=46&tid=15
    Description
    Agency for Toxic Substances and Disease Registry. Public Health Statement for Cadmium. Agency for Toxic Substances and Disease Registry (ATSDR). 2012. Toxicological Profile for Cadmium
    URL
    http://nj.gov/health/eoh/rtkweb/documents/fs/1349.pdf
    Description
    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
    Description
    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
    https://seer.cancer.gov/statfacts/html/leuks.html
    Description
    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
    Description
    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
    Description
    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
    Description
    Mayo Clinic. Chronic lymphocytic leukemia. Blood Test Information
    URL
    https://www.cancer.net/cancer-types/leukemia-chronic-lymphocytic-cll/statistics
    Description
    American Society of Clinical Oncology (ASCO). Leukemia - Chronic Lymphocytic - CLL: Statistics. Approved by the Cancer.Net Editorial Board, 06/2016

    Learn more about this trial

    Chronic Lymphocytic Leukemia Responds to Dermal Chelation

    We'll reach out to this number within 24 hrs