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

Phase 2

Completed

Interventions: Device: Modulated Electro-Hyperthermia (mEHT)
Drug: IPCI (CDDP+5FU)
Dietary Supplement: TCM Herbal Decoction (Shi Pi)

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).

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Study Group	TCM Herbal Decoction (Shi Pi)	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.
Study Group	Modulated Electro-Hyperthermia (mEHT)	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.
Control Group	IPCI (CDDP+5FU)	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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

Name	Time	Method
Quality of Life (QoL)	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%.
Adverse Events Rate (AER)	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.