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

NCT02638051 | Completed Phase 2 Results

• 1 other identifier: OT-CH-PCMA-14
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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).

Conditions

Peritoneal Neoplasms; Ascites; Yang Deficiency; Yin Deficiency

Keywords

Peritoneal Carcinomatosis; Malignant Ascites; Modulated Electro-Hyperthermia; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks after start of treatment (4 weeks on completion of treatment)

Secondary Outcomes (2)

• Adverse Events Rate (AER)

  During 4 weeks of treatment course and 4 weeks after treatment

• Quality of Life (QoL)

  8 weeks after start of treatment (4 weeks on completion of treatment)

Study Arms (2)

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.

Device: Modulated Electro-Hyperthermia (mEHT); Dietary Supplement: TCM Herbal Decoction (Shi Pi)

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.

Drug: IPCI (CDDP+5FU)

Interventions

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.

Also known as: Oncothermia

Study Group

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.

Also known as: Shi Pi Decoction

Study Group

IPCI (CDDP+5FU) DRUG

Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galenic Research Institute Ltd: lead

Study Sites (1)

Clifford Hospital

Guangzhou, Guangdong, 511495, China

Location

Related Publications (8)

• 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.

  PMID: 22590662 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.

  PMID: 19240999 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.

  PMID: 24562547 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.

  PMID: 25842096 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.

  PMID: 24973890 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.

  PMID: 26472466 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.

  PMID: 21644239 BACKGROUND

• 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.

  PMID: 28529748 RESULT

MeSH Terms

Conditions

Peritoneal Neoplasms; Ascites; Yang Deficiency; Yin Deficiency

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* Absence of the detailed peritoneal carcinomatosis characteristics. * Absence of a survival analysis. These limitations are related to the restricted funding of the trial.

Results Point of Contact

• Title: Prof. Clifford LK Pang, President of Clifford Hospital
• Organization: Clifford Hospital

cpang@cliffordgroup.com

(8620) 34710038

Study Officials

• Clifford LK Pang, PhD

  Clifford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 22, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 19, 2017
• Results First Posted: March 28, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)