A phase II, single-arm clinical trial involving an alternative cancer treatment psorinum therapy in patients with advanced esoph

A phase II, single-arm clinical trial involving an alternative cancer treatment psorinum therapy in patients with advanced esophageal carcinoma.

Critical Cancer Management Research Centre and Clinic, Kolkata, India; Chittaranjan National Cancer Institute, Kolkata, India; R. G. Kar Medical College and Hospital, Kolkata, India

Abstract Disclosures

Abstract

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Background: We prospectively studied the clinical efficacy of an alternative cancer treatment "psorinum therapy" in patients with advanced esophageal carcinoma (ECA).Methods: Our study was phase- II, open level, single arm and single stage. Participants’ eligibility criteria included (1) histopathology confirmation of ECA; (2) inoperable tumor (3) no prior conventional cancer treatments (4) Karnofsky performance status between 40- 70%. The primary outcome measures of the study were (1) to assess the radiological tumor response rate (using CT scanning procedure and following the RECIST criteria); (2) to assess how many participants survived at least 1 yr, 2 yrs, 3 yrs, 4 yrs, and finally, after 5 yrs of the study. The secondary outcome measure was to assess the side effects of the investigational anti- cancer drug (psorinum) if any. The drug psorinum (an alcoholic extract of scabies, slough and pus cells) was administered orally at 0.02ml/ Kg body weight / day as a single dose in empty stomach and ongoing for complete course duration of 2 years to all the participants along with allopathic and homeopathic supportive cares. Results: 65 participants included in the final analysis at the end of the study. According to the RECIST criteria, complete tumor response occurred in 11 (16.92%) cases and partial response occurred in 20 (30.77%) cases. 44 (67.69%) of them survived at least 1 yr, 32 (49.23%) survived at least 2 yrs, 24 (36.92%) survived at least 3 years, 21 (32.31%) survived at least 4 years and 17 (26.15%) of them survived at least 5 years. These participants did not receive conventional or any other investigational cancer treatments. Conclusions: The results of the study show clinical efficacy of psorinum therapy in treating patients with advanced esophageal carcinoma. The investigational drug psorinum is non- toxic. Randomized controlled clinical trial should be conducted for further investigation of this alternative cancer treatment in treating esophageal carcinoma