Clinical trial NCT02638051: Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Neoplasms
Ascites
Yang Deficiency
Yin Deficiency
Keywords: Peritoneal Carcinomatosis
Malignant Ascites
Modulated Electro-Hyperthermia
Traditional Chinese Medicine
Lead sponsor: Galenic Research Institute Ltd
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed PC with malignant ascites.
* Karnofsky Performance Status (KPS) score ≥60%.
* Normal function of bone marrow.
* Predicted survival time \>1 month.
* Written informed consent.

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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 8 weeks after start of treatment (4 weeks on completion of treatment)
Secondary outcomes:
measure: Adverse Events Rate (AER)
timeFrame: During 4 weeks of treatment course and 4 weeks after treatment
measure: Quality of Life (QoL)
timeFrame: 8 weeks after start of treatment (4 weeks on completion of treatment)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Clifford Hospital
state: Guangdong
Study officials:
affiliation: Clifford Hospital
name: Clifford LK Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pang CLK, Zhang X, Wang Z, Ou J, Lu Y, Chen P, Zhao C, Wang X, Zhang H, Roussakow SV. Local modulated electro-hyperthermia in combination with traditional Chinese medicine vs. intraperitoneal chemoinfusion for the treatment of peritoneal carcinomatosis with malignant ascites: A phase II randomized trial. Mol Clin Oncol. 2017 May;6(5):723-732. doi: 10.3892/mco.2017.1221. Epub 2017 Apr 10.