Background Currently, the main goal of cancer research is to increase longevity of patients suffering malignant cancers. The promising results of BCc1 in vitro and vivo experiments made us look into the effect of BCc1 nanomedicine on patients with cancer in a clinical trial. Methods The present investigation was a randomized, double-blind, placebo-controlled, parallel, and multicenter study in which 123 patients (30-to-85-year-old men and women) with metastatic and non-metastatic gastric cancer, in two separate groups of BCc1 nanomedicine or placebo, were selected using a permuted block randomization method. For metastatic and non-metastatic patients, a daily dose of 3000 and 1500 mg was prescribed, respectively. Overall survival (OS) as the primary endpoint and quality of life (measured using QLQ-STO22) and adverse effects as the secondary endpoints were studied. Results In metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (174 days [95% confidence interval (CI) 82.37–265.62]) than in placebo (62 days [95% CI 0–153.42]); hazard ratio (HR): 0.5 [95% CI 0.25–0.98; p = 0.046]. In non-metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (529 days [95% CI 393.245–664.75]) than in placebo (345 days [95% CI 134.85–555.14]); HR: 0.324 [95% CI 0.97–1.07; p = 0.066]. The QLQ-STO22 assessment showed a mean difference improvement of 3.25 and 2.29 ( p value > 0.05) in BCc1 nanomedicine and a mean difference deterioration of − 4.42 and − 3 (p-value < 0.05) in placebo with metastatic and non-metastatic patients, respectively. No adverse effects were observed. Conclusion The findings of this trial has provided evidence for the potential capacity of BCc1 nanomedicine for treatment of cancer. Trial registration IRCTID, IRCT2017101935423N1. Registered on 19 October 2017, http://www.irct.ir/ IRCT2017101935423N1 Electronic supplementary material The online version of this article (10.1186/s12951-019-0484-0) contains supplementary material, which is available to authorized users.
background The prevalence of breast cancer and its mortality rate are increasing rapidly among women worldwide. on other hand, the courses of chemotherapy as the main treatment for these patients are too much exhaustive and annoying. this study was designed to evaluate the effects of synbiotics (probiotics + prebiotics) supplementation as a safe and inexpensive adjuvant treatment in reducing common chemotherapy side effects in women with breast cancer. Methods The current study was carried out on 67 women with definitive breast cancer diagnosis who were hospitalized to receive one-day chemotherapy sessions and met inclusion criteria. Patients were randomly allocated to the intervention or control group to receive synbiotics or placebo, respectively. Twice a day oral consumption of synbiotics supplements for 8 weeks. The primary outcome was the changes in severity or experience of chemotherapy complication, analyzed by intention to treat (ITT). Using 7 validated questionnaires, chemotherapy complications in initiation, 4 weeks and 8 weeks after intervention were assessed. Dietary intake was measured by 24-h dietary recall at beginning, 4th and 8th weeks. We used version 24 of SPSS software for statistical analysis. P-value < 0.05 was considered as statistically significant. Results Sixty seven breast cancer patients completed the study. After 8 weeks of intervention and adjusting confounders, the severity of chemotherapy complications including, fatigue (P < 0/001) and unnormal defecation (P = 0.005) decreased significantly in the synbiotic group compared to the placebo group. Also, nausea/vomiting (P = 0.015), and anorexia (P < 0.001) were decreased in the end of the study compared to the first visit, but it was not statistically significant compared to the placebo group. conclusions Synbiotics supplementation during chemotherapy can potentially reduce the severity of fatigue and abnormal defecation. It can also be promising in reducing anorexia and nausea/vomiting. Trial Registration this study was registered in the Iranian Registry of Clinical Trials (IRCT) (registered code: IRCT20091114002709N56) (date of registration: 5/5/2021). direct link to the trial page: https://www.irct.ir/trial/54559
Background: Nowadays, one criterion to assess the impact of various treatments in cancer patients is the quality of life (QOL), which represents the patients' physical and psychosocial manner. It is already proved that BCc1 nanomedicine enjoys therapeutic behavior in cancer treatment of in vitro, animal, and human studies. Objectives: In the present study, we aimed at investigating the QOL in gastric cancer patients according to the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) questionnaire after treating them with BCc1 nanomedicine synthesized based on nanochelating technology. Methods: A randomized, double-blind, and multicenter study was conducted to investigate the QLQ-STO30 of 60 metastatic (8 weeks after treatment) and 60 non-metastatic (20 weeks after treatment) gastric cancer patients in two separate groups named BCc1 nanomedicine and placebo. Results: In the metastatic patients, the mean difference of overall QLQ-STO30 showed a 2.8-score improvement in BCc1 nanomedicine (P < 0.05) and a 5.2-score decline in placebo (P < 0.05); in non-metastatic patients, it showed a 2.3-score improvement in BCc1 nanomedicine (P > 0.05) and a 3-score decline in placebo (P > 0.05). Conclusions:The results of the study showed that BCc1 nanomedicine improves a number of indices in metastatic and nonmetastatic gastric cancer patients, such as functional domains, symptom scales, and global QOL included in EORTC QLQ-STO30 questionnaire.
Context: COVID-19 pandemic has resulted in considerable overloading of health care systems in almost all regions of the world. Among different malignancies, breast cancer can be considered as a typical example of how the decision-making process for radiation treatment can be adapted to unusual situations. There exist several international guidelines in order to modify radiotherapy treatments during the COVID-19 pandemic, however, some of their recommendations are not applicable in regions with limited resources. In this manuscript, we provided guidance to deliver radiotherapy to patients with breast cancer during the COVID-19 pandemic based on our available nationwide resources. Evidence Acquisition: A team of expert radiation oncologists convened multidisciplinary and cross-institutional meetings and reviewed the major internationally published guidelines and relevant literature in the field of breast radiotherapy during the COVID-19 pandemic in order to establish recommendations for the safe application of radiation regimens based on the national limited resources. Results: Practical guidance in order to deliver radiotherapy to patients with breast cancer during the COVID-19 pandemic based on available nationwide resources was developed. Conclusions: Many of the international recommendations on the breast cancer radiotherapy during COVID-19 outbreak are not applicable in countries with limited resources. Therefore, modifying the guidelines based on the available resources is mandatory in order to achieve the best possible results.
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