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
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
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
NCT ID
NCT03495492
First Posted
February 14, 2018
Last Updated
April 4, 2018
Sponsor
Optimum Health, Natural Healthcare Center
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
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Chronic Lymphocytic Leukemia Responds to Dermal Chelation
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