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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638051
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : March 28, 2016
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Galenic Research Institute Ltd

Study Description
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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).

Condition or disease Intervention/treatment Phase
Peritoneal Neoplasms Ascites Yang Deficiency Yin Deficiency Device: Modulated Electro-Hyperthermia (mEHT) Dietary Supplement: TCM Herbal Decoction (Shi Pi) Drug: IPCI (CDDP+5FU) Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.
Other Name: Oncothermia

Dietary Supplement: 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.
Other Name: Shi Pi Decoction
Active Comparator: 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.
 Drug: IPCI (CDDP+5FU)
Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 8 weeks after start of treatment (4 weeks on completion of treatment) ]

    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 :
  1. Adverse Events Rate (AER) [ Time Frame: During 4 weeks of treatment course and 4 weeks after treatment ]
    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.

  2. Quality of Life (QoL) [ Time Frame: 8 weeks after start of treatment (4 weeks on completion of treatment) ]

    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%.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638051


Locations
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China, Guangdong
Clifford Hospital
Guangzhou, Guangdong, China, 511495
Sponsors and Collaborators
Galenic Research Institute Ltd
Investigators
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Principal Investigator: Clifford LK Pang, PhD Clifford Hospital
More Information
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Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 10.3892/mco.2017.1221
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,

Publications of Results:

Other Publications:

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Responsible Party: Galenic Research Institute Ltd
ClinicalTrials.gov Identifier: NCT02638051    
Other Study ID Numbers: OT-CH-PCMA-14
First Posted: December 22, 2015    Key Record Dates
Results First Posted: March 28, 2016
Last Update Posted: May 19, 2017
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Galenic Research Institute Ltd:
Peritoneal Carcinomatosis
Malignant Ascites
Modulated Electro-Hyperthermia
Traditional Chinese Medicine
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Ascites
Yin Deficiency
Yang Deficiency
Pathologic Processes
Neoplasms
 Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases