NCT02638051

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Galenic Research Institute Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Peritoneal Neoplasms
• Ascites
• Yang Deficiency
• Yin Deficiency

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2015-12-22
• Last updated: 2017-05-19
• Results posted: 2016-03-28

Locations

1 site across 1 country: China