Overview

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

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Galenic Research Institute Ltd
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.