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This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).
Conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) is based on chemoinfusion with its inherent toxicity. There is a strong demand for a safe and non-toxic method of treatment of PCMA. The new technology of modulated electro-hyperthermia (mEHT) has proven efficacy in many advanced cancers with minimal side effects and synergy with Traditional Chinese Medicine (TCM). TCM has a long history of application at advanced cancer as a symptomatic treatment and enhancer of the general resistance of the organism. Shi Pi Decoction is supposed to be the optimum co-treatment of PCMA according to principles of TCM. Intraperitoneal chemoinfusion (IPCI) with cisplatin and fluorouracil is a widespread standard treatment of PCMA in China. This randomized II phase trial studies efficacy and safety of combination of mEHT with TCM in treatment of PCMA versus standard IPCI (CDDP+5FU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | 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. |
|
| Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modulated Electro-Hyperthermia (mEHT) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR) WHO criteria of therapeutic effect evaluation at malignant ascites:
| 8 weeks after start of treatment (4 weeks on completion of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Rate (AER) | Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute. | During 4 weeks of treatment course and 4 weeks after treatment |
| Quality of Life (QoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clifford LK Pang, PhD | Clifford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clifford Hospital | Guangzhou | Guangdong | 511495 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22590662 | Background | 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. | |
| 19240999 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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There was no any pre-assignment dropout or exclusion.
From January 3, 2014 to December 20, 2014, 260 patients were recruited in Clifford Hospital. They were randomly allocated in two groups with 130 patients in each group.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| TCM Herbal Decoction (Shi Pi) | Dietary Supplement | Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang. |
|
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| IPCI (CDDP+5FU) | Drug | Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm). |
|
Karnofsky Performance Score Improvement Rate (KPS IR)
|
| 8 weeks after start of treatment (4 weeks on completion of treatment) |
| 24562547 | Background | 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. |
| 25842096 | Background | 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. |
| 24973890 | Background | 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. |
| 26472466 | Background | 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. |
| 21644239 | Background | 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. |
| 28529748 | Result | 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. |
| 10.3892/mco.2017.1221 | Clinical Study Report | View IPD | 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, |
| FG001 | 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 was 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). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Primary Disease | Number | participants |
| ||||||||||||||||
| Metastases | Number | participants |
| ||||||||||||||||
| Stage | Peritoneal carcinomatosis itself is considered III stage; evidence of distant metastases means IV stage. | Number | participants |
| |||||||||||||||
| Karnofsky Performance Score | KPS 90% - symptomatic patients with normal daily activity. KPS 80% - normal daily activity with effort. KPS 70% - limited daily activity (unable to work), complete self-care. KPS 60% - limited daily activity (unable to work), limited self-care (needs assistance), active >50% of daytime. KPS <60% (Perforce inactive (sits or lies) ≥50% of daytime) excluded. | Number | participants |
| |||||||||||||||
| CDDP (Intraperitoneal Chemoinfusion) Dose Per Session | Mean | Standard Deviation | mg |
| |||||||||||||||
| 5-FU (Intraperitoneal Chemoinfusion) Dose Per Session | Mean | Standard Deviation | mg/sqm |
| |||||||||||||||
| Interventions | Median | Full Range | sessions |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR) WHO criteria of therapeutic effect evaluation at malignant ascites:
| Posted | Number | percentage of participants | 8 weeks after start of treatment (4 weeks on completion of treatment) |
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| Secondary | Adverse Events Rate (AER) | Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute. | Posted | Number | participants | During 4 weeks of treatment course and 4 weeks after treatment |
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| Secondary | Quality of Life (QoL) | Karnofsky Performance Score Improvement Rate (KPS IR)
| Posted | Number | percentage of participants | 8 weeks after start of treatment (4 weeks on completion of treatment) |
|
2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 130 | 3 | 130 | ||
| EG001 | 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). | 0 | 130 | 16 | 130 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marow depression | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal Reactions | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Damage of hepatic function | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Damage of renal function | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Clifford LK Pang, President of Clifford Hospital | Clifford Hospital | (8620) 34710038 | cpang@cliffordgroup.com |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| D001201 | Ascites |
| D016711 | Yang Deficiency |
| D016710 | Yin Deficiency |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Colon Cancer |
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| Rectal Cancer |
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| Pancreatic Cancer |
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| Endometrial Cancer |
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| Ovarian Cancer |
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| Liver Cancer |
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| Liver |
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| Celiac lymph nodes |
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| Bones |
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| II |
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| III |
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| IV |
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| 70 |
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| 80 |
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| 90 |
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| TCM |
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| IPCI |
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