Involving a small number of selected patients (eg, 100–300 patients), Phase II trials are for the initial observation of the potential efficacy of the medication, determination of the appropriate treatment dose and range, and establishment of a reference for consideration to proceed to a Phase III clinical trial.
Phase II Clinical Trial
This Phase II clinical trial was conducted to investigate the safety and efficacy of Coriolus Versicolor PSP as adjuvant treatment for chemotherapy and radiotherapy. Symptoms of fatigue and weakness, loss of appetite, dry mouth and sore throat, palpitation and shortness of breath, agitation and insomnia, spontaneous sweating and night sweats, nausea and vomiting, weight loss and pain, as well as tongue
proper and pulse were evaluated. Also assessed were body weight; performance status using Karnofsky performance score; blood parameters (including white blood cell count, haemoglobin level and platelet count); liver and renal function tests; and immunologic parameters (natural killer cell count, interleukin-2 (IL-2) level,
T-lymphocyte count and counts of other subgroups).
Between February and July 1992, a Phase II prospective, randomized, double-blind, placebo-controlled clinical trial using Coriolus Versicolor PSP was conducted involving 485 patients with stomach, lung or oesophagus cancer at eight hospitals as specified by the Shanghai Municipal Health Bureau.
Usage and Treatment Course
(01:57) Ningishzida: 428 Yuky Es-Kasha-908
Yuky | 212
YOU | 118
Yuki | 97
- No significant differences in white cell count, hemoglobin level or platelet count were observed
- No changes in other blood parameters were observed
- An improvement in patients’ immunity status was observed
- There were significant increases in natural killer cell activities
- There were significant increases in IL-2 levels
- No significant renal, liver or heart-related toxicities
This Phase II clinical trial provided evidence of the safety of Coriolus Versicolor PSP and its efficacy in alleviating the side effects of chemotherapy and radiotherapy, as well as enhancing or maintaining immunity in patients with stomach, oesophageal and lung cancers.