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

Ascites Clinical Trial

— OTMA-RII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638051
• Other study ID #: OT-CH-PCMA-14
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2015
• Last updated: December 18, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Galenic Research Institute Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Peritoneal Neoplasms
• Yang Deficiency
• Yin Deficiency

Intervention

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)
Inpraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).

Locations

Country	Name	City	State
China	Clifford Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Galenic Research Institute Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Reaponse Rate (ORR)	Complete Remission and Partial Remission (CR + PR)	8 weeks after start of treatment (4 weeks on completion of treatment)	No
Secondary	Adverse Events Rate (AER)		During 4 weeks of treatment course and 4 weeks after treatment	Yes
Secondary	Quality of Life (QoL)	Karnofsky Performance Score Improvement Rate (KPS IR)	8 weeks after start of treatment (4 weeks on completion of treatment)	No