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

The purpose of this study was to develop a safe and non-toxic alternative to the conventional conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) by investigating the efficacy and safety of local modulated electro-hyperthermia (mEHT) combined with the traditional Chines...

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Published in:Molecular and clinical oncology 2017-05, Vol.6 (5), p.723-732
Main Authors: Pang, Clifford L K, Zhang, Xinting, Wang, Zhen, Ou, Junwen, Lu, Yimin, Chen, Pengfei, Zhao, Changlin, Wang, Xiaopu, Zhang, Hongyu, Roussakow, Sergey V
Format: Article
Language:English
Subjects:
Abdomen
Analysis
Ascites
Blood
Bone marrow
Cancer therapies
Carcinoma
Care and treatment
Chemotherapy
Chinese medicine
Comparative analysis
Diuretics
Fever
Gastric cancer
Hyperthermia
Medical prognosis
Oncology
Quality of life
Response rates
Spleen
Studies
Thermotherapy
Toxicity
Traditional Chinese medicine
Treatment outcome
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Summary:The purpose of this study was to develop a safe and non-toxic alternative to the conventional conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) by investigating the efficacy and safety of local modulated electro-hyperthermia (mEHT) combined with the traditional Chinese medicine (TCM) 'Shi Pi' herbal decoction, compared with standard intraperitoneal chemoinfusion (IPCI). A randomized, controlled, single-center, open-label clinical trial (phase II) with two parallel groups (allocation ratio, 1:1) was conducted to investigate the efficacy and safety of mEHT+TCM (study group, SG) vs. standard IPCI (control group, CG) in patients with PCMA by intention-to-treat analysis. A total of 260 patients with PCMA were randomly allocated into the two groups (130/130); mEHT was applied for 60 min per session every second day for 4 weeks, for a total of 14 sessions. The TCM decoction was administered orally, at 400 ml daily. In CG, occlusive IPCI with cisplatin (30-60 mg) and fluorouracil (500-600 mg/m ) was applied twice, biweekly. The objective response rate (ORR), quality of life (QoL) and adverse event rate (AER) in the two groups were evaluated 1 month after treatment, analyzed and compared. The present study is registered on ClinicalTrials.gov (NCT02638051). No case was lost or excluded (0/260). The ORR in SG was 77.69% (101/130) vs. 63.85% (73/130) in CG (P
ISSN:2049-9450
2049-9469
DOI:10.3892/mco.2017.1221