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

62 Background: We prospectively studied the clinical efficacy of an alternative cancer treatment "psorinum therapy" in treating 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. Psorinum (an alcoholic extract of scabies slough and pus cells) was administered orally at a dose of 0.02ml / kg body weight / day as a single dose on an empty stomach for a complete course duration of 2 yrs 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 response occurred in 11 (16.92%) case 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 yrs, 21 (32.31%) survived at least 4 yrs and 17 (26.15%) of them survived at least 5 yrs. These participants didn't receive conventional or any other investigational cancer treatments. According to AJCC TNM staging system, 31 (47.69%) participants diagnosed at stage IV. Among them complete response observed in 4 (12.90%) cases, partial response observed in 8 (25.81%) cases and 5 (16.13%) of them survived at least 5 yrs.


CONCLUSIONS
The results of the study show clinical efficacy of psorinum therapy in treating patients with advanced ECA. 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 cancer.