Safety and Preliminary Efficacy of Herbal Formulary “N040” in Advanced Cervical Cancer: A Clinical Trial Phase 1b

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Monthaka Teerachaisakul thanut Khuayjarernpanishk Wiwan Worakunphanich Kamonwam Bancheun Anchalee Chaiyasat Thavatchai Kamoltham

Abstract

Cervical cancer is the second most common cancer among Thai women. Fifteen out of 100 women will survive for 5 years or more after being diagnosed cervical cancer stage IV. Recent publications reveal that Traditional herbal formulary combined with standard treatment can increase the survival rate among patients with cancer. This study, therefore, aimed to investigate safety and preliminary effect of N040 in patients with advanced cervical cancer whom were not eligible for standard treatment. This study is a clinical trial phase 1b. Forty-four patients diagnosed with advanced cervical cancer were recruited. One capsule containing 267.50 mg. of N040 extraction was prescribed 2 times a day for 6 months. The patients were assessed every 4 weeks for 36 weeks. Baseline characteristics and blood examinations were evaluated 6 times (24 weeks). Diagnostic radiology was conducted at week 1, 12 and 36. Assessment of RECIST Criteria was compared at week 1 and 36, while quality of life scores using T-FLIC2 was compared at week 1 and 24. One-year survival rate was also performed. Statistical analysis using ratio, mean, paired t-test, Repeated One-way ANOVA and Kaplan Meier Method were calculated. Intention to treat was applied. The results showed that only 32 patients were eligible for the study. The mean age and BMI of patients were 53.31 + 10.29 years and 22.64 + 4.28 kg/m2 respectively. Percent neutrophils, Blood Urea Nitrogen (BUN) and Alkaline phosphatase (ALP) were significantly increased within the normal range after receiving N040 capsule. The RECIST Criteria showed that 20 patients (62.5%) responded to N040 medication. However, the T-FLIC 2 scores, serum level of CEA and CA19-9 were not significant different. During 1-year follow-up there were 12 deaths which represented one-year survival rate at 62.50%. No report of serious adverse event. In conclusion, this study found that N040 is safe for patients with advanced cervical cancer. About 62.5% of the patient response to the medication. However, further clinical trials with control group should be conducted to confirm the efficacy of this herbal formulary.


 

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Author Biography

Monthaka Teerachaisakul, Thai Traditional Medicine Research Institute, Department of Thai Traditional and Alternative Medicine, Ministry of Public health, Nonthaburi 11000, Thailand.

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