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

NCT02638051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2017-05-19

Study results available
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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

Interventions

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.

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.

DRUG

IPCI (CDDP+5FU)

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

Sponsors & Collaborators

  • Galenic Research Institute Ltd

    lead OTHER

Principal Investigators

  • Clifford LK Pang, PhD · Clifford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02638051 on ClinicalTrials.gov