Conditions: Peritoneal Neoplasms Ascites Yang Deficiency Yin Deficiency
Keywords: Peritoneal Carcinomatosis Malignant Ascites Modulated Electro-Hyperthermia Traditional Chinese Medicine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

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).

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).

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Modulated Electro-Hyperthermia (mEHT) intervention 2: TCM Herbal Decoction (Shi Pi) intervention 3: IPCI (CDDP+5FU)
Intervention descriptions: intervention 1: 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. intervention 2: Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang. intervention 3: Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).

Protocol document: