NCT02638051 - Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT | Biotech Hunter

Enrollment

260

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2015

Conditions

Peritoneal NeoplasmsAscitesYang DeficiencyYin 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).

Trial Locations (1)

511495

Clifford Hospital, Guangzhou