Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT (OTMA-RII)
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|ClinicalTrials.gov Identifier: NCT02638051|
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : March 28, 2016
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Neoplasms Ascites Yang Deficiency Yin Deficiency||Device: Modulated Electro-Hyperthermia (mEHT) Dietary Supplement: TCM Herbal Decoction (Shi Pi) Drug: IPCI (CDDP+5FU)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2015|
Experimental: Study Group
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.
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.
Other Name: Oncothermia
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.
Other Name: Shi Pi Decoction
Active Comparator: Control Group
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.
Drug: IPCI (CDDP+5FU)
Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
- Objective Response Rate (ORR) [ Time Frame: 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.
- Adverse Events Rate (AER) [ Time Frame: 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.
- Quality of Life (QoL) [ Time Frame: 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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638051
|Guangzhou, Guangdong, China, 511495|
|Principal Investigator:||Clifford LK Pang, PhD||Clifford Hospital|