Chronic Lymphocytic Leukemia Responds to Dermal Chelation

NCT ID: NCT03495492

Last Updated: 2018-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lymphocytic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Clinical trials with a single arm
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants

Group receiving dermal chelation and nutritional therapy

Group Type EXPERIMENTAL

Dermal Chelation

Intervention Type DEVICE

Dermal chelation with Aqua DetoxTM system for one or more hours one or more times each week.

Nutritional Therapy

Intervention Type DIETARY_SUPPLEMENT

Vitamins and minerals that will be taken one or more times a day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dermal Chelation

Dermal chelation with Aqua DetoxTM system for one or more hours one or more times each week.

Intervention Type DEVICE

Nutritional Therapy

Vitamins and minerals that will be taken one or more times a day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Optimum Health, Natural Healthcare Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19742163 (View on PubMed)

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.

Reference Type RESULT
PMID: 9630463 (View on PubMed)

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.

Reference Type RESULT
PMID: 22293416 (View on PubMed)

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.

Reference Type RESULT
PMID: 22945569 (View on PubMed)

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.

Reference Type RESULT
PMID: 1131339 (View on PubMed)

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.

Reference Type RESULT
PMID: 11333192 (View on PubMed)

Wani AL, Ara A, Usmani JA. Lead toxicity: a review. Interdiscip Toxicol. 2015 Jun;8(2):55-64. doi: 10.1515/intox-2015-0009.

Reference Type RESULT
PMID: 27486361 (View on PubMed)

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.

Reference Type RESULT
PMID: 21827276 (View on PubMed)

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.

Reference Type RESULT
PMID: 26264017 (View on PubMed)

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.

Reference Type RESULT
PMID: 24368178 (View on PubMed)

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.

Reference Type RESULT
PMID: 19897186 (View on PubMed)

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.

Reference Type RESULT
PMID: 3149183 (View on PubMed)

Stelzer KJ, Pazdernik TL. Cadmium-induced immunotoxicity. Int J Immunopharmacol. 1983;5(6):541-8. doi: 10.1016/0192-0561(83)90047-4.

Reference Type RESULT
PMID: 6363310 (View on PubMed)

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.

Reference Type RESULT
PMID: 1250252 (View on PubMed)

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.

Reference Type RESULT
PMID: 15689032 (View on PubMed)

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.

Reference Type RESULT
PMID: 15092991 (View on PubMed)

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.

Reference Type RESULT
PMID: 4513535 (View on PubMed)

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.

Reference Type RESULT
PMID: 2738890 (View on PubMed)

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.

Reference Type RESULT
PMID: 1009120 (View on PubMed)

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.

Reference Type RESULT
PMID: 25445091 (View on PubMed)

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.

Reference Type RESULT
PMID: 14965792 (View on PubMed)

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.

Reference Type RESULT
PMID: 25009099 (View on PubMed)

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.

Reference Type RESULT
PMID: 4609793 (View on PubMed)

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.

Reference Type RESULT
PMID: 1719661 (View on PubMed)

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.

Reference Type RESULT
PMID: 10771143 (View on PubMed)

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.

Reference Type RESULT
PMID: 22235210 (View on PubMed)

Rose TP. Sterilization of carious dentine with silver nitrate. Chronicle. 1976 Oct;39(8):151, 159. No abstract available.

Reference Type RESULT
PMID: 1068773 (View on PubMed)

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.

Reference Type RESULT
PMID: 7023931 (View on PubMed)

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.

Reference Type RESULT
PMID: 11703167 (View on PubMed)

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.

Reference Type RESULT
PMID: 6824602 (View on PubMed)

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.

Reference Type RESULT
PMID: 26508811 (View on PubMed)

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.

Reference Type RESULT
PMID: 26185180 (View on PubMed)

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.

Reference Type RESULT
PMID: 21540277 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.niehs.nih.gov/health/topics/agents/mercury/index.cfm

National Institute of Environmental Health Science Information on Mercury

https://www.mayoclinic.org/diseases-conditions/enlarged-spleen/symptoms-causes/syc-20354326

Mayo Clinic. "Enlarged spleen (splenomegaly)." Mayo Foundation for Medical Education and Research (MFMER) 1998-2017.

http://www.merckmanuals.com/home/blood-disorders/spleen-disorders/overview-of-the-spleen

Jacob, Harry S. "Overview of the spleen." Merck Manual. Last full review/revision November 2016

https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/what-is-all.html

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.

https://www.ncbi.nlm.nih.gov/books/NBK261/

Chapter 153, The White Blood Cell and Differential Count

https://www.hopkinsmedicine.org/kimmel_cancer_center/centers/leukemia_program/current_treatments.html

Johns Hopkins Medicine. Leukemia Treatments. The Sidney Kimmel Comprehensive Cancer Center

http://nj.gov/health/eoh/rtkweb/documents/fs/1349.pdf

New Jersey Department of Health. Right to Know Hazardous Substance Fact Sheet. Revision 4/2010

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20714_NICOTROL%20INHALER%2010MG,%20CARTRIDE_EAFONSI.PDF

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.

http://journals.sagepub.com/doi/abs/10.1191/0960327104ht472oa?journalCode=hetb

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

https://seer.cancer.gov/statfacts/html/leuks.html

National Cancer Institute. Cancer Stat Facts: Leukemia. Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute. SEER Data, 1973-2014.

https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq#section/_30

National Cancer Institute at the National Institutes of Health. Chronic Lymphocytic Leukemia Treatment. Updated: October 26, 2017.

https://www.hopkinsmedicine.org/kimmel_cancer_center/centers/leukemia_program/current_treatments.html

Johns Hopkins Medicine. Leukemia Treatments. The Sidney Kimmel Comprehensive Cancer Center 1973-

https://www.cancer.net/cancer-types/leukemia-chronic-lymphocytic-cll/statistics

American Society of Clinical Oncology (ASCO). Leukemia - Chronic Lymphocytic - CLL: Statistics. Approved by the Cancer.Net Editorial Board, 06/2016

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DCCLL2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.