ABSTRACT
Background: Radiation induced proctitis is frequently encountered during the radiation therapy of cervical and prostate cancers that causes pain and occasionally with bleeding and may affect the continuity of radiation therapy. Aims and Objectives: The purpose of the study is to look at the benefit of administration of an oral prebiotic amylase resistant starch in reducing the incidence of acute radiation proctitis, a distressing symptom in patients receiving radiation therapy for cancer of the cervix. Material and Methods: The study was conducted between 2011 and 2014 in 104 patients receiving radical chemo-radiotherapy for carcinoma cervix. Patients were randomized in to two arms, one receiving 30 gm of resistant starch and the other digestible starch on a daily basis throughout the course of the external radiotherapy. All patients received standard 4-field box radiation portals, 50 Gy in 25 fractions with 4 cycles of weekly concurrent Cisplatin. At completion of external beam radiotherapy, all patients underwent LDR/HDR brachytherapy. The study was double blinded and allocation was concealed from the investigators. The investigator recorded the radiotherapy related toxicity of the patients according to CTC V 3.0. The incidence and severity of grade 2-4 diarrhoea and proctitis were documented on a weekly basis and compared across the two groups and analyzed. Stool short chain fatty acid concentrations were measured at baseline at 2nd and 4th week and after 6 weeks of completion of radiotherapy in both study placebo arms and reported. The pattern of microbiota in the stool were also estimated in all patients at 4 time points. Two patients who progressed during therapy were not included in the analyses and two patients discontinued the intervention. A per protocol analyses was done. Results: At analysis there were 50 patients in each arm. The severity of clinical proctitis was found to be similar in both groups of patients with 12.2 % of patients experiencing toxicity of grade 2 and above in digestible starch group versus 14.6% in the resistant starch group. Functional proctitis was similarly graded and it was found that 16.3 % patients in digestible starch group experienced toxicity against 10.2 % patients in the resistant starch group. This difference was seen at 4th week and continued in the subsequent weeks till the end of radiation. Both groups had similar reported toxicity at 6 weeks post intervention and similar incidence of grade 2 and above diarrhea. The resistant starch group was found to have 8% incidence as compared to 2% in the other group at the 5th and 6th week. The short chain fatty acid concentrations were not significantly different in the groups at any point. Conclusion: The study did not demonstrate a significant benefit in administering resistant starch over and above normal diet to patients receiving pelvic radiotherapy. The reasons may be attributed to concurrent use of chemotherapy and decrease in intestinal probiotics. The use of digestible starch in the control arm may have contributed to lower incidence of the toxicity endpoints as well
ABSTRACT
Background: Obstetric outcome in women with advanced maternal age (AMA) is not usually studied especially in India.Methods: This study was a case control study. The cases were pregnancy in 100 women at 40 years of age and beyond and there were two control arms of 100 each of ages 20-29 years and 30-39 years. The demography, maternal complications, delivery outcomes and neonatal outcomes were compared.Results: Women with AMA were mostly multiparous and had higher Body Mass Index (BMI). Hypertensive disease in pregnancy was more common in AMA but the difference was statistically significant. Women with AMA were more likely to have gestational diabetes (p ≤0.011), more likely to have anemia (p=0.038), more likely to have preterm birth (p=0.001), other medical complications compare to the control group (p=0.005). They were also more likely to have Lower Segment Caesarean Section (LSCS) (p ≤0.001) and have postpartum complications. The birth weight of the neonate was significantly decreased in the AMA group (p <0.001). The neonates were also more likely to be admitted to Neonatal Intensive Care Unit (NICU) (p ≤0.006).Conclusions: Adverse maternal and neonatal outcomes were seen despite individualized and optimal obstetric care. Thus, these women need preconceptional counselling.