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Background: Cervical cancer is the fourth most common cancer among women globally, with quality of life (QOL) being a major concern for patients with cervical cancer, especially in low- and middle-income countries (LMICs). This is largely due to the advanced nature of the disease at presentation. Although there are a higher number of studies focusing on the QOL of high-income countries, the QOL of cervical cancer patients in LMICs is not available. The aim of this study is to evaluate QOL among women with cervical cancer in Nigeria using a 2-point assessment. Methods: A multi-center prospective cohort study will be conducted in 6 tertiary health facilities randomly selected from the 6 geopolitical zones of Nigeria and consisting of a 2-point assessment of the QOL of participants at the time of diagnosis of cervical cancer and after treatment. Women who were recently diagnosed with histologically confirmed cervical cancer (treatment naïve) will be included. QOL will be assessed using Quality of Life Questionnaire domains (EORTC QLQ30) as developed by the European Organization for Research and Treatment of Cancer (EORTC). In addition to the QOL assessment, relevant and clinicopathological variables will be obtained using a self-structured data extraction sheet designed for this study. All data will be anonymized and will be analyzed using SPSS version 25. Levels of QOL will be calculated using EORTC QLQ30. Ethical approval was obtained from National Health Research Ethics Committee (NHREC/01/01/2007-08/11/2021). Discussion: In view of the paucity of data on QOL in LMICs like Nigeria, where most women with cervical cancer present with advanced disease, this research was designed to help in formulating evidence-based interventions to improve the QOL and treatment outcomes provided to women with cervical cancer in Nigeria and other LMICs. The study is expected to fill these knowledge gaps.
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BACKGROUND: To our knowledge, there is no prior randomized trial on the efficacy of Mojeaga remedy (a special blend of Alchornea cordifolia, Pennisetum glaucum and Sorghum bicolor extracts) when co-administered with standard-of-care for correction of anemia in obstetrics practice. This study determined the efficacy, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetric population. METHODS: A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga group) for 2 weeks or conventional iron therapy alone without Mojeaga (standard-of-care group) for 2 weeks. Repeat hematocrit level were done 2 weeks post-initial therapy. Primary outcome measures were changes in hematocrit level and median hematocrit level at two weeks post therapy. Maternal adverse events and neonatal outcomes (birth anomalies, low birthweight, preterm rupture of membranes and preterm labor) were considered the safety outcome measures. Analysis was by intention-to-treat. RESULTS: Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.00±4.00%;p<0.001) and median hematocrit values (31.00±2.00% vs 27.00±3.00%;p<0.001) were significantly higher in the Mojeaga group. There were no treatment-related serious adverse events, congenital anomalies or deaths in the Mojeaga group and incidence of other neonatal outcomes were similar (p>0.05). CONCLUSION: Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes. CLINICAL TRIAL REGISTRATION: www.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).