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Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT (OTMA-RII)

Primary Purpose

Peritoneal Neoplasms, Ascites, Yang Deficiency

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Modulated Electro-Hyperthermia (mEHT)
TCM Herbal Decoction (Shi Pi)
IPCI (CDDP+5FU)
Sponsored by
Galenic Research Institute Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Neoplasms focused on measuring Peritoneal Carcinomatosis, Malignant Ascites, Modulated Electro-Hyperthermia, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed PC with malignant ascites.
  • Karnofsky Performance Status (KPS) score ≥60%.
  • Normal function of bone marrow.
  • Predicted survival time >1 month.
  • Written informed consent.

Exclusion Criteria:

  • Surgery within 3 weeks or not full recovery of postoperative suture.
  • 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.

Sites / Locations

  • Clifford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR) WHO criteria of therapeutic effect evaluation at malignant ascites: Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month. Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month. No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention.

Secondary Outcome Measures

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.
Quality of Life (QoL)
Karnofsky Performance Score Improvement Rate (KPS IR) Improvement: increase of KPS for ≥10% after treatment. Worsening: reduction of KPS for ≥10% after treatment. NC: change of KPS for <10%.

Full Information

First Posted
December 17, 2015
Last Updated
April 15, 2017
Sponsor
Galenic Research Institute Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02638051
Brief Title
Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT
Acronym
OTMA-RII
Official Title
Local Modulated Electro-Hyperthermia in Combination With Traditional Chinese Medicine Versus Intraperitoneal Chemoinfusion in Treatment of Peritoneal Carcinomatosis With Malignant Ascites: A Phase II Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galenic Research Institute Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Neoplasms, Ascites, Yang Deficiency, Yin Deficiency
Keywords
Peritoneal Carcinomatosis, Malignant Ascites, Modulated Electro-Hyperthermia, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Modulated Electro-Hyperthermia (mEHT)
Other Intervention Name(s)
Oncothermia
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
TCM Herbal Decoction (Shi Pi)
Other Intervention Name(s)
Shi Pi Decoction
Intervention Description
Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
Intervention Type
Drug
Intervention Name(s)
IPCI (CDDP+5FU)
Intervention Description
Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR) WHO criteria of therapeutic effect evaluation at malignant ascites: Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month. Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month. No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention.
Time Frame
8 weeks after start of treatment (4 weeks on completion of treatment)
Secondary Outcome Measure Information:
Title
Adverse Events Rate (AER)
Description
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.
Time Frame
During 4 weeks of treatment course and 4 weeks after treatment
Title
Quality of Life (QoL)
Description
Karnofsky Performance Score Improvement Rate (KPS IR) Improvement: increase of KPS for ≥10% after treatment. Worsening: reduction of KPS for ≥10% after treatment. NC: change of KPS for <10%.
Time Frame
8 weeks after start of treatment (4 weeks on completion of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed PC with malignant ascites. Karnofsky Performance Status (KPS) score ≥60%. Normal function of bone marrow. Predicted survival time >1 month. Written informed consent. Exclusion Criteria: Surgery within 3 weeks or not full recovery of postoperative suture. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford LK Pang, PhD
Organizational Affiliation
Clifford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clifford Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511495
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22590662
Citation
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.
Results Reference
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PubMed Identifier
19240999
Citation
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.
Results Reference
background
PubMed Identifier
24562547
Citation
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.
Results Reference
background
PubMed Identifier
25842096
Citation
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.
Results Reference
background
PubMed Identifier
24973890
Citation
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.
Results Reference
background
PubMed Identifier
26472466
Citation
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.
Results Reference
background
PubMed Identifier
21644239
Citation
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.
Results Reference
background
PubMed Identifier
28529748
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.spandidos-publications.com/mco/6/5/723?articleTypes=ARTICLE&articleTypes=REVIEW&fileTypes=LETTER_TO_THE_EDITOR&fileTypes=MANUSCRIPT&fileTypes=TABLE&fileTypes=IMAGE&fileTypes=LANG_EDIT
Available IPD/Information Identifier
10.3892/mco.2017.1221
Available IPD/Information Comments
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,

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Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT

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