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

  • Authors:
    • Clifford L.K. Pang
    • Xinting Zhang
    • Zhen Wang
    • Junwen Ou
    • Yimin Lu
    • Pengfei Chen
    • Changlin Zhao
    • Xiaopu Wang
    • Hongyu Zhang
    • Sergey V. Roussakow
  • View Affiliations

  • Published online on: April 10, 2017     https://doi.org/10.3892/mco.2017.1221
  • Pages: 723-732
Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )
Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )


Abstract

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/m2) 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<0.05). The QoL in SG was 49.23% vs. 32.3% in CG (P<0.05). The AER in SG was 2.3% (3/130) vs. 12.3% (16/130) in CG (P<0.05). All the adverse events were grade I. In conclusion, the combination of mEHT with TCM achieves better control of PCMA compared with standard IPCI, with less toxicity. Both components of the combination are non‑toxic treatments easily tolerated by patients. Thus, this combined treatment may be preferred due to the better benefit-harm balance.
View Figures
View References

Related Articles

Journal Cover

May 2017
Volume 6 Issue 5

Print ISSN: 2049-9450
Online ISSN:2049-9469

Sign up for eToc alerts

Recommend to Library

Copy and paste a formatted citation
x
APA
Pang, C.L., Zhang, X., Wang, Z., Ou, J., Lu, Y., Chen, P. ... Roussakow, S.V. (2017). 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. Molecular and Clinical Oncology, 6, 723-732. https://doi.org/10.3892/mco.2017.1221
MLA
Pang, C. L., Zhang, X., Wang, Z., Ou, J., Lu, Y., Chen, P., Zhao, C., Wang, X., Zhang, H., Roussakow, S. V."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". Molecular and Clinical Oncology 6.5 (2017): 723-732.
Chicago
Pang, C. L., Zhang, X., Wang, Z., Ou, J., Lu, Y., Chen, P., Zhao, C., Wang, X., Zhang, H., Roussakow, S. V."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". Molecular and Clinical Oncology 6, no. 5 (2017): 723-732. https://doi.org/10.3892/mco.2017.1221