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Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

Introduction: Hand-foot syndrome (HFS) is a common cutaneous side effect of capecitabine therapy. Apart from oral cyclooxygenase-2 (COX-2) inhibitor (celecoxib), there are no proven strategies for the prevention of HFS. However, celecoxib is associated with significant cardiotoxicity. To date, no study has evaluated the role of topical COX inhibitor, diclofenac. In this study, we aim to compare topical 1% diclofenac gel with placebo in the prevention of capecitabine-induced HFS.Methods: This is a randomized, placebo-controlled, double-blind, parallel-group superiority trial: the Diclofenac Topical in Reducing Capecitabine induced HFS (D-TORCH) study. A total of 264 patients with breast and gastrointestinal malignancies will be randomly allocated (stratified by sex and type of therapy [monotherapy or combination regimen with capecitabine]) to receive either 1% topical diclofenac or placebo that will be applied over the palmar and dorsal surface of the hands twice daily whilst taking capecitabine for 12 weeks. The patients will be followed up until the end of four cycles. The primary objective of this study is to compare the effect of topical diclofenac with placebo in preventing HFS (incidence of NCI CTCAEv5.0 grade 2 or higher HFS). The secondary objective is to compare the effect of topical diclofenac with placebo on preventing all grades of HFS (incidence of NCI CTCv5.0 all grade HFS), time to develop HFS (from the start of capecitabine), patient-reported outcomes (PROs) (HF-HRQoL questionnaire), adherence with the application (self-reported), capecitabine dose changes (number of patients with dose modifications due to HFS) and safety profile (NCICTCv5.0 all grade HFS) DISCUSSION: The D-TORCH study aims to determine if 1% topical diclofenac reduces the incidence of grade 2 or higher HFS in patients receiving capecitabine. To date, there have been a lot of trials for hand-foot syndrome prevention using agents like pyridoxine, vitamin E, carvedilol, and various polyherbal formulations, but none has been found successful. If the trial meets the primary end point, 1% topical diclofenac will be the new standard of care for HFS prevention.Trial Registration: Clinical Trials Registry of India  CTRI/2021/01/030592 . Prospectively registered on January 19, 2021. [ABSTRACT FROM AUTHOR]

Objective: The prevalence of anemia has remained high among Indian adolescent girls over the past decade, despite the ongoing iron and folic acid (IFA) supplementation program. This study was conducted to assess the impact of daily supplementation of a package of IFA with vitamin B12 on hemoglobin levels among adolescent girls.Methods: A community-based cluster-randomized trial was conducted in the rural block of Faridabad District, Haryana, India in the year 2017. A total of 760 adolescent girls in the age group of 12-19 years with mild and moderate anemia were selected from government schools. Daily-supervised administration of iron and folic acid was conducted for 90 days: experimental group-IFA (iron (60 mg), folic acid (500) mcg), and cyanocobalamin (1000 mcg), control group-IFA and placebo. Hemoglobin, serum ferritin, and vitamin B12 levels were assessed at baseline and endline.Results: Two-hundred adolescent girls completed 90 doses of daily supplementation. The mean hemoglobin (experimental group: 1.3 ± 1.0 g/dL, control group: 1.6 ± 1.2 g/dL, P = 0.004) and ferritin levels (experimental group: 18.6 ± 31.5 ng/mL, control group: 18.8 ± 35.0 ng/mL, P = 0.188) increased in both the control and experiment groups. Serum vitamin B12 deficiency significantly reduced to 2.5% in the experimental group and ferritin deficiency alleviated in more than 96% of the girls post intervention.Conclusions: Daily supplementation of IFA with/without vitamin B12 for 90 days eliminated iron, vitamin B12 deficiency and reduced the overall proportion of anemia by 53.5%. However, addition of vitamin B12 to IFA supplementation had no impact on improving the hemoglobin levels among adolescent girls. The present study does not recommend provision of vitamin B12 for prevention and treatment of anemia in this population group. [ABSTRACT FROM AUTHOR]

The present study explores the efficacy of 12-week yoga+diet-based lifestyle intervention (YBLI) vs dietary intervention (DI) on health-related quality of life (HRQoL) and identifies the predictors of change in HRQoL in Indians with metabolic syndrome (Met S). Data from the historical randomized controlled trial was used including adults (n=260, 20-45 years) with Met S. Four domains of HRQoL were measured at baseline, 2 and 12 weeks using WHOQOLBREF questionnaire. Generalized estimating equation and chi-square test was used to compare 12-week changes in HRQoL domains and proportion of subjects, respectively. Changes in HRQoL were predicted using regression models concerning changes in body mass index (BMI), physical activity, total calorie intake, adiponectin, and superoxide dismutase (SOD) levels. Exploratory mediation analysis was carried out using Baron & Kenny approach. YBLI resulted in a significantly greater increase in the physical domain score of HRQoL than DI. A significantly greater proportion of subjects in YBLI group (71%) showed an increase in physical domain scores compared to DI (51%). A unit change in BMI negatively predicted a unit change in physical, psychological and environmental health. Whereas, a unit change in adiponectin and SOD levels positively predicted a unit change in physical and environmental health. Partial mediation between YBLI intervention and physical HRQoL domain was observed via adiponectin. In conclusion, a 12-week YBLI has a positive and greater effect on HRQoL physical domain score than following DI alone. Changes in BMI, adiponectin, and SOD levels may predict changes in HRQoL domains after lifestyle intervention. [ABSTRACT FROM AUTHOR]

Metabolic syndrome, a prediabetic and precardiovascular pathologic condition that begins early in life, tracks into adulthood and magnifies with age. Randomized controlled trials evaluating efficacy of yoga-based lifestyle vs. dietary intervention on metabolic syndrome are lacking. Here, the efficacy of a 12-week yoga-based lifestyle intervention vs. dietary intervention on cardio-metabolic risk factors and metabolic syndrome risk scores have been assessed in Indian adults with metabolic syndrome. In this two-arm, open label, parallel group, randomized controlled trial, 260 adults (20–45 years) diagnosed with metabolic syndrome as per joint interim statement, 2009 were randomized to yoga-based (including diet) lifestyle or dietary intervention alone (n = 130, each) for 12 weeks. Primary endpoints were the 12-week changes in cardio-metabolic risk factors and metabolic risk scores. The secondary endpoints were the 12-week changes in the proportion of subjects recovered from metabolic syndrome, dietary intake, and physical activity. Intent-to-treat analysis was performed including all the subjects with baseline data with imputed missing data. Treatment × time interaction showed yoga-based lifestyle intervention had a greater treatment effect over dietary intervention by significantly reducing waist circumference, continuous metabolic syndrome z-score, and dietary intake/day while significantly increasing physical activity. High-density lipoprotein cholesterol showed a significantly greater reduction following dietary intervention than yoga-based lifestyle intervention. A significantly greater proportion of subjects recovered from metabolic syndrome in yoga-based lifestyle (45.4%) vs. dietary intervention group (32.3%). A 12-week yoga-based lifestyle intervention is more efficacious than usual dietary intervention in improving cardio-metabolic risk factor and metabolic risk score in Indian adults with metabolic syndrome. [ABSTRACT FROM AUTHOR]

The article discusses breast conservation surgery followed by radiotherapy has the management of choice for early-stage breast cancer. Topics include postmenopausal women with hormone receptor–positive breast cancer, breast conservation surgery and staged between pT1- 3N0-1M0 have included; and aromatase inhibitors have become the adjuvant hormonal therapy of choice for postmenopausal women tamoxifen continues to used in the premenopausal setting.

Abstract: Purpose: The objective of this randomized single blind (outcome assessor) controlled trial was to evaluate the efficacy of 4weeks of modified constraint induced movement therapy (mCIMT) in improving upper limb function in 3–8years old children with hemiplegic cerebral palsy. Methods: Thirty-one children were randomly assigned to receive the mCIMT (N =16) with conventional therapy or conventional therapy alone (N =15). Children were evaluated three times (at enrollment, follow up at 4weeks and 12weeks). The primary outcome measure was difference in “change in mean total QUEST scores” at 4weeks of intervention between the intervention and the control arm. Results: After 4weeks of intervention, mCIMT group showed significant change in the affected upper limb in QUEST scores (10.7±5.2 vs 1.4±1.7, p <0.001) and time (s) to complete nine-hole-pegboard test compared with control group [60(0–130) vs 5(−12 to 30), p <0.001]. The improvement observed in upper limb function after 4weeks of intervention persisted 8weeks after discontinuation of intervention in mCIMT group. Conclusion: The modified constraint induced movement therapy appears to be effective in improving upper limb function in 3–8years old hemiplegic cerebral palsy children. [Copyright &y& Elsevier]