Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT
NCT ID: NCT02638051
Last Updated: 2017-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2014-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study Group
Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Modulated Electro-Hyperthermia (mEHT)
MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi)
Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
Control Group
IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU)
Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
Interventions
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Modulated Electro-Hyperthermia (mEHT)
MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
TCM Herbal Decoction (Shi Pi)
Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
IPCI (CDDP+5FU)
Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky Performance Status (KPS) score ≥60%.
* Normal function of bone marrow.
* Predicted survival time \>1 month.
* Written informed consent.
Exclusion Criteria
* Active bleeding or vascular occlusion in the mEHT treatment area.
* Emotional instability.
* Impossibility to place the patient into the mEHT machine.
* Metallic implants or replacements in the treatment area.
* Electronic implanted devices anywhere.
* Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area.
* Very low white blood cell count (\<1.5×10(9)/L), agranulocytosis (\<0.5×10(9)/L) or severe anemia.
18 Years
75 Years
ALL
No
Sponsors
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Galenic Research Institute Ltd
OTHER
Responsible Party
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Principal Investigators
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Clifford LK Pang, PhD
Role: PRINCIPAL_INVESTIGATOR
Clifford Hospital
Locations
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Clifford Hospital
Guangzhou, Guangdong, China
Countries
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References
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Sangisetty SL, Miner TJ. Malignant ascites: A review of prognostic factors, pathophysiology and therapeutic measures. World J Gastrointest Surg. 2012 Apr 27;4(4):87-95. doi: 10.4240/wjgs.v4.i4.87.
Andocs G, Renner H, Balogh L, Fonyad L, Jakab C, Szasz A. Strong synergy of heat and modulated electromagnetic field in tumor cell killing. Strahlenther Onkol. 2009 Feb;185(2):120-6. doi: 10.1007/s00066-009-1903-1. Epub 2009 Feb 25.
Meggyeshazi N, Andocs G, Balogh L, Balla P, Kiszner G, Teleki I, Jeney A, Krenacs T. DNA fragmentation and caspase-independent programmed cell death by modulated electrohyperthermia. Strahlenther Onkol. 2014 Sep;190(9):815-22. doi: 10.1007/s00066-014-0617-1. Epub 2014 Feb 22.
Ling Y. Traditional Chinese medicine in the treatment of symptoms in patients with advanced cancer. Ann Palliat Med. 2013 Jul;2(3):141-52. doi: 10.3978/j.issn.2224-5820.2013.04.05.
Andocs G, Meggyeshazi N, Balogh L, Spisak S, Maros ME, Balla P, Kiszner G, Teleki I, Kovago C, Krenacs T. Upregulation of heat shock proteins and the promotion of damage-associated molecular pattern signals in a colorectal cancer model by modulated electrohyperthermia. Cell Stress Chaperones. 2015 Jan;20(1):37-46. doi: 10.1007/s12192-014-0523-6. Epub 2014 Jun 29.
Tsang YW, Huang CC, Yang KL, Chi MS, Chiang HC, Wang YS, Andocs G, Szasz A, Li WT, Chi KH. Improving immunological tumor microenvironment using electro-hyperthermia followed by dendritic cell immunotherapy. BMC Cancer. 2015 Oct 15;15:708. doi: 10.1186/s12885-015-1690-2.
Matharu G, Tucker O, Alderson D. Systematic review of intraperitoneal chemotherapy for gastric cancer. Br J Surg. 2011 Sep;98(9):1225-35. doi: 10.1002/bjs.7586. Epub 2011 Jun 6.
Pang CLK, Zhang X, Wang Z, Ou J, Lu Y, Chen P, Zhao C, Wang X, Zhang H, Roussakow SV. Local modulated electro-hyperthermia in combination with traditional Chinese medicine vs. intraperitoneal chemoinfusion for the treatment of peritoneal carcinomatosis with malignant ascites: A phase II randomized trial. Mol Clin Oncol. 2017 May;6(5):723-732. doi: 10.3892/mco.2017.1221. Epub 2017 Apr 10.
Study Documents
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Document Type: Clinical Study Report
Pang CLK, Zhang X, Wang Z, Ou J, Lu Y, Chen P, Zhao C, Wang X, Zhang H, Roussakow SV. Local modulated electro-hyperthermia in combination with traditional Chinese medicine vs. intraperitoneal chemoinfusion for the treatment of peritoneal carcinomatosis with malignant ascites: A phase II randomized trial. Mol Clin Oncol. 2017;6:723-32,
View DocumentOther Identifiers
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OT-CH-PCMA-14
Identifier Type: -
Identifier Source: org_study_id
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