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Background: A novel nanosomal paclitaxel lipid suspension (NPLS), free from Cremophor EL (CrEL) and ethanol, was developed to address the solvent-related toxicities associated with conventional paclitaxel formulation. Objective: To evaluate the efficacy and safety of NPLS versus CrEL-based paclitaxel (conventional paclitaxel) in patients with metastatic breast cancer (MBC). Design: A prospective, open-label, randomized, multiple-dose, parallel, phase II/III study. Methods: Adult (18–65 years) female patients with MBC who had previously failed at least one line of chemotherapy were randomized (2:2:1) to NPLS 175 mg/m2 every 3 weeks (Q3W, n = 48, arm A), NPLS 80 mg/m2 every week (QW, n = 45, arm B) without premedication or conventional paclitaxel (Taxol®, manufactured by Bristol-Myers Squibb, Princeton, NJ, USA) 175 mg/m2 Q3W (n = 27, arm C) with premedication. In the extension study, an additional 54 patients were randomized (2:1) to arm A (n = 37) or arm C (n = 17). Results: Pooled data from the primary study and its extension phase included 174 patients. The primary endpoint was the overall response rate (ORR). As per intent-to-treat analysis, ORR was significantly better in the NPLS QW arm as compared to conventional paclitaxel [44.4% (20/45) versus 22.7% (10/44), (p = 0.04)]. An improvement in ORR with NPLS Q3W versus conventional paclitaxel arm [29.4% (25/85) versus 22.7% (10/44)] (p = 0.53) was observed. Disease control rates observed were improved with NPLS Q3W versus conventional paclitaxel Q3W (77.7% versus 72.7%, p = 0.66) and with NPLS QW versus conventional paclitaxel Q3W (84.4% versus 72.7%, p = 0.20), although not significant. A lower incidence of grade III/IV peripheral sensory neuropathy, vomiting, and dyspnea was reported with NPLS Q3W versus conventional paclitaxel Q3W arms. Conclusion: NPLS demonstrated an improved tumor response rate and a favorable safety profile versus conventional paclitaxel. NPLS 80 mg/m2 QW demonstrated a significantly better response versus conventional paclitaxel 175 mg/m2 Q3W. Trial registration: Clinical Trial Registry-India (CTRI), CTRI/2010/091/001344 Registered on: 18 October 2010 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MjEzNQ==&Enc=&userName=CTRI/2010/091/001344), CTRI/2015/07/006062 Registered on: 31 July 2015 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE2Mjc=&Enc=&userName=CTRI/2015/07/006062) Plain language summary: Role of nanosomal paclitaxel lipid suspension (NPLS) in the treatment of patients with metastatic breast cancer (MBC) Why was the study done? Paclitaxel is a commonly used drug for the treatment of breast cancer. Conventional formulation of paclitaxel is known to cause side effects like injection site reactions. A newer formulation named NPLS was developed to overcome the limitations of the conventional paclitaxel. The current study was done to compare the safety and effectiveness of NPLS and conventional paclitaxel in patients with advanced breast cancer. What did the researchers do? The research team conducted a large study in multiple hospitals across India, involving women with advanced breast cancer who had experienced treatment failure with previous chemotherapy. A total of 174 patients were randomly assigned to receive either of the three treatment schedules: (1) NPLS every 3 weeks, (2) NPLS every week, (3) conventional paclitaxel every 3 weeks. What did the researchers find? The results showed that NPLS, in a weekly schedule, led to better tumor response rates compared to conventional paclitaxel given every 3 weeks. Additionally, NPLS demonstrated a favorable safety profile, as compared to conventional paclitaxel. What do the findings mean? These findings suggest that NPLS could be a promising alternative for women with advanced breast cancer. NPLS improved the response to treatment, with a better safety profile compared to conventional paclitaxel. [ABSTRACT FROM AUTHOR]

Introduction: Hematological cancer patients often experience anxiety, depression, and fatigue during chemotherapy. Addressing these issues can improve the quality of life and long-term well-being. This study evaluated the effects of pranayama and mindfulness meditation intervention on emotional distress and fatigue in hematological cancer patients undergoing chemotherapy. Materials and Methods: Adult hematological cancer patients undergoing chemotherapy (n = 27) were randomized into the intervention group (n = 12) or control group (n = 15). Baseline and post-6 weeks assessment was made using the Emotion Thermometer (ET) and Fatigue Assessment Scale (FAS). The intervention included daily practice of slow-paced pranayama and mindfulness meditation for 15 min each. Results: Statistical software SPSS v20.0 was used for data analysis. Within the intervention group, the pre–post comparisons indicated a statistically significant reduction in distress (p = 0.002), anxiety (p = 0.02), anger (p = 0.03), depression (p = 0.004), and need for help (p = 0.0005) scores of ET. Total fatigue (p = 0.002), physical fatigue (p = 0.002), and mental fatigue (p = 0.002) scores of FAS declined significantly within the intervention group. There was no statistically significant improvement for any parameter of ET or FAS within the control group. Between the groups, comparison showed a statistically significant reduction in distress (p = 0.004), anxiety (p = 0.02), anger (p = 0.03), need for help (p < 0.0005), total fatigue scores (p < 0.0001), physical fatigue (p < 0.0001), and mental fatigue (p < 0.0001) in the intervention group as compared to the control group. Conclusion: The results suggest the potential role of integrated pranayama and mindfulness meditation intervention in reducing emotional distress and fatigue in hematological cancer patients undergoing chemotherapy. Further validation with a larger sample size is required. [ABSTRACT FROM AUTHOR]

Context: Significant psychological morbidity with stress, depression, and anxiety has been reported in head-and-neck cancer (HNC) patients undergoing curative treatment. Failure to detect and treat psychological distress affects the outcomes of cancer therapies and decreases patients' quality of life (QoL). Studies have reported the benefits of yoga for anxiety, symptom severity, and distress in cancer patients. Aims: To identify the effects of yoga therapy on psychological distress and QoL in HNC patients undergoing radiotherapy. Settings and Design: Single-group, pretest posttest study in a clinical setting. Subjects and Methods: Psycho-Oncology Assessment Questionnaire, Distress Thermometer, European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0, and EORTC QLQ-H&N35 questionnaires were administered to HNC patients (n = 22) before and after yoga intervention during 6 weeks of radiotherapy. The yoga intervention included loosening practices, asana, pranayama, and meditation. Statistical Analysis: Data were analyzed in statistical software - STATA, version 10.1 (2011). Results: Significant reduction in psychological distress (p = 0.0001) and improvement in the QoL (p = 0.0001) was observed. Significant improvement in physical, emotional, cognitive, social, and role functioning (p = 0.0001) was observed. Significant reduction in QLQ-C30 symptom subscale scores of insomnia, pain, appetite loss, and fatigue (p = 0.0001) was observed. Significant reduction in H&N35 symptom subscale scores related to swallowing, opening the mouth (p = 0.0001), trouble with social eating, trouble with social contact, and felt ill (p < 0.05) was observed. Conclusion: Yoga therapy intervention significantly reduced the psychological distress, improved the QoL, improved functions, and reduced symptoms in HNC patients undergoing radiotherapy. Further validation is required by conducting randomized controlled trials with a larger sample size. [ABSTRACT FROM AUTHOR]

Abstract Background Complications of suprapubic catheter insertion are rare but can be significant. We describe an unusual complication of a delayed bowel perforation following suprapubic catheter insertion. Case presentation A gentleman presented with features of peritonitis and feculent discharge along a suprapubic catheter two months after insertion of the catheter. Conclusion Bowel perforation is the most feared complication of suprapubic catheter insertion especially in patients with lower abdominal scar. The risk may be reduced with the use of ultrasound scan guidance.