Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT (OTMA-RII)

Galenic Research Institute Ltd

Status and phase: Completed; Phase 2

Conditions: Yin Deficiency; Peritoneal Neoplasms; Yang Deficiency; Ascites

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02638051

OT-CH-PCMA-14

Details and patient eligibility

About

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).

Full 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).

Enrollment: 260 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Study Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: TCM Herbal Decoction (Shi Pi)

Device: Modulated Electro-Hyperthermia (mEHT)

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: IPCI (CDDP+5FU)