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Background This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer. Methods In an individually-randomized cross-over trial patients with gynecological cancer, 4 to 6 planned chemotherapy cycles were included. Thirty-four patients were randomized to STF in the first half of chemotherapies followed by normocaloric diet (group A; n  = 18) or vice versa (group B; n  = 16). Fasting started 36 h before and ended 24 h after chemotherapy (60 h-fasting period). QOL was assessed by the FACIT-measurement system. Results The chemotherapy-induced reduction of QOL was less than the Minimally Important Difference (MID; FACT-G = 5) with STF but greater than the MID for non-fasted periods. The mean chemotherapy-induced deterioration of total FACIT-F was 10.4 ± 5.3 for fasted and 27.0 ± 6.3 for non-fasted cycles in group A and 14.1 ± 5.6 for non-fasted and 11.0 ± 5.6 for fasted cycles in group B. There were no serious adverse effects. Conclusion STF during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. Trial registration This trial was registered at clinicaltrials.gov: NCT01954836 .

Background Traditional, Complementary, and Integrative Medicine (TCIM) is widely used in Germany. Approximately 70% of the German population report lifetime use, with 32% indicating usage within the past year and 18% currently. This study examines the association between TCIM utilization and health-related factors, including sociodemographic characteristics and health-related quality of life (HRQoL) in Germany. Methods An online survey of 4,065 German adults (aged 18–75) was conducted in 2022. HRQoL was assessed with globally recognized and extensively validated instruments using the EQ-5D-5 L descriptive system and index values. We compared HRQoL based on age, gender, income, TCIM use and attitudes, medical conditions, dietary patterns, and social milieus (Sinus-Milieus ® ). The EQ-5D-5 L index ranges from 1 (perfect health) to ≤ 0 (death), EQ VAS from 100 (best imaginable health) to 0 (worst imaginable health). Results The mean ± standard error and median (interquartile range) were 68.2 ± 0.4 and 73.0 (32.5) for EQ VAS, and 0.85 ± 0.00 and 0.92 (0.18) for the EQ-5D-5 L index. Lower HRQoL was observed among women, older adults, and individuals with lower socioeconomic status. TCIM users within the past 12 months (31.8%) had significantly lower EQ-5D-5 L index scores (0.82 ± 0.01; 0.90 [0.17]) than non-users (0.87 ± 0.00; 0.94 [0.17]; p  < 0.001) and reported a significantly higher disease burden (88.0% vs. 68.6%). Musculoskeletal disorders were the most common condition (35.8%), associated with an EQ-5D-5 L index of 0.71 ± 0.01 and EQ VAS of 56.9 ± 0.6. Neurological conditions were linked to the lowest HRQoL, whereas allergies were associated with the highest. Dietary patterns significantly influenced HRQoL, with pescatarians reporting the highest and raw foodists the lowest scores. Among social milieus, the “Precarious Milieu” had the lowest EQ-5D-5 L index (median 0.86 [0.28]), while the “Performer Milieu” had the highest (0.97 [0.11]). Conclusion The findings underscore the influence of sociodemographic and socioeconomic determinants on HRQoL and highlight health disparities across social groups. The inverse association between TCIM use and HRQoL may reflect a higher burden of chronic conditions and unmet healthcare needs among TCIM users. Further research is warranted to investigate causal relationships and the role of TCIM in addressing complex health challenges. Trial registration ClinicalTrials.gov (NCT05530720).

Placental-site trophoblastic tumours are a rare form of gestational trophoblastic disease and consequently information about optimum management or prognostic factors is restricted. We aimed to assess the long-term outcome of stage-adapted management by surgery, chemotherapy, or both for patients with the disorder. 35 550 women were registered with gestational trophoblastic disease in the UK (1976–2006), of whom 62 were diagnosed with placental-site trophoblastic tumours and included, retrospectively, in the study. Patients were treated by surgery, chemotherapy, or both. We estimated the probabilities of overall survival and survival without recurrence of disease 5 and 10 years after the date of first treatment, and calculated the association of these endpoints with prognostic factors, including time since antecedent pregnancy, serum concentration of β-human chorionic gonadotropin, and stage of disease, with both univariate and multivariate analyses. Probabilities of overall and recurrence-free survival 10 years after first treatment were 70% (95% CI 54–82) and 73% (54–85), respectively. Patients with stage I disease had a 10-year probability of overall survival of 90% (77–100) and did not benefit from postoperative chemotherapy. By contrast, patients with stage II, III, and IV disease required combined treatment with surgery and chemotherapy; probability of overall survival at 10 years was 52% (3–100) for patients with stage II disease and 49% (26–72) for stage III or IV disease. Outcome for patients who had recurrent or refractory disease was poor: only four (22%) patients achieved long-term survival beyond 60 months. Multivariate analysis showed that the only significant independent predictor of overall and recurrence-free survival was time since antecedent pregnancy. A cutoff point of 48 months since antecedent pregnancy could differentiate between patients' probability of survival (<48 months) or death (≥48 months) with 93% specificity and 100% sensitivity, and with a positive predictive value of 100% and a negative predictive value of 98%. Stage-adapted management with surgery for stage I disease, and combined surgery and chemotherapy for stage II, III, and IV disease could improve the effectiveness of treatment for placental-site trophoblastic tumours. Use of 48 months since antecedent pregnancy as a prognostic indicator of survival could help select patients for risk-adapted treatment. National Commissioning Group.

Radiotherapy (RT) is of critical importance in the locoregional management of early breast cancer. Although RT is routinely used following breast conserving surgery (BCS), patients may occasionally be effectively treated with BCS alone. Currently, the selection of patients undergoing BCS who do not need breast irradiation is under investigation. With the advancement of personalized medicine, there is an increasing interest in reduction of aggressive treatments especially in older women. The primary objective of this study was to identify elderly patients who may forego breast irradiation after BCS without measurable consequences on local tumor growth and survival. We analyzed 2384 early breast cancer patients aged 70 and older who were treated in 17 German certified breast cancer centers between 2001 and 2009. We compared RT versus no RT after guideline adherent (GA) BCS. The outcomes studied were breast cancer recurrence (RFS) and breast cancer-specific survival (BCSS). Low-risk patients were defined by luminal A, tumor size T1 or T2 and node-negative whereas higher-risk patients were defined by patients with G3 or T3/T4 or node-positive or other than Luminal A tumors. To test if there is a difference between two or more survival curves, we used the Gp family of tests of Harrington and Fleming. The median age was 77 yrs (mean 77.6±5.6 y) and the median observation time 46 mths (mean 48.9±24.8 mths). 950 (39.8%) patients were low-risk and 1434 (60.2%) were higher-risk. 1298 (54.4%) patients received GA BCS of which 85.0% (1103) received GA-RT and only 15% (195) did not. For low-risk patients with GA-BCS there were no significant differences in RFS (log rank p = 0.651) and in BCSS (p = 0.573) stratified by GA-RT. 5 years RFS in both groups were > 97%. For higher-risk patients with GA-BCS we found a significant difference (p<0.001) in RFS and tumor-associated OS stratified by GA-RT. The results remain the same after adjusting by adjuvant systemic treatment (AST) and comorbidity (ASA and NYHA). Patients aged 70 years and older suffering from low-risk early breast cancer with GA-BCS can avoid breast irradiation with <3% chance of relapse. In the case of higher-risk, breast irradiation should be used routinely following GA-BCS. As a side effect of these results, removing the entire breast of elderly low risk patients to spare them from breast irradiation seems to be not necessary.

In this study based on the BRENDA data, we investigated the impact of endocrine ± chemotherapy for luminal A, nodal positive breast cancer on recurrence free (RFS) and overall survival (OS). In addition, we analysed if tumor size of luminal A breast cancer influences survival in patients with the same number of positive lymph nodes. In this retrospective multi-centre cohort study data of 1376 nodal-positive patients with primary diagnosis of luminal A breast cancer during 2001-2008 were analysed. The results were stratified by therapy and adjusted by age, tumor size and number of affected lymph nodes. In our study population, patients had a good to excellent prognosis (5-year RFS: 91% and tumorspecific 5-year OS 96.5%). There was no significant difference in RFS stratified by patients with only endocrine therapy and with endocrine plus chemo-therapy. Patients with 1-3 affected lymph nodes had no significant differences in OS treated only with endocrine therapy or with endocrine plus chemotherapy, independent of tumor size. Patients with large tumors and more than 3 affected lymph nodes had a significant worse survival as compared to the small tumors. However, despite the worse prognosis of those, adjuvant chemotherapy failed in order to improve RFS. According to our data, nodal positive patients with luminal A breast cancer have, if any, a limited benefit of adjuvant chemotherapy. Tumor size and nodal status seem to be of prognostic value in terms of survival, however both tumor size as well as nodal status were not predictive for a benefit of adjuvant chemotherapy.

Older representative surveys show that Traditional, Complementary and Integrative Medicine (TCIM) is used by about 60% of the German population. However, no data exists for the current nationwide situation. The main aim of this cross-sectional study is to investigate the current use and acceptance of TCIM in Germany. This study is based on a representative sample of the German population aged 18-75 years. Participants were asked about the use and acceptance of TCIM. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022 by three renowned German market research institutes on behalf of and in close coordination with the working group. The data set was analyzed descriptively and inferentially. In total, 4,065 participants (52% female, 48% male, 0.4% diverse) responded completely (response rate: 21.5%). Among participants, 70% stated that they had used TCIM at some point in their lives, with 32% doing so in the last 12 months and 18% currently. The most common reason given (17%) was musculoskeletal pain. For their own health, 39% stated that TCIM is important. Traditional European Medicine was rated as very/mainly effective by 27% of participants and as partly effective by 44% (conventional medicine: 69% very/mainly effective, 19% partly effective). As a complementary treatment strategy to conventional medicine, 35% considered TCIM to be optimal (\"Complementary Medicine\"), 33% in combination with conventional medicine (\"Integrative Medicine\") and 5% without conventional medicine (\"Alternative Medicine\"). The majority of the participants were in favor of more research on TCIM and stated that the costs of TCIM services should be covered by health insurance companies (71% and 69%, respectively). These results from a representative online-population suggest that the use of TCIM in Germany remains at a high level. The nationwide relevance of TCIM should be given greater consideration in German health care policy making. TCIM should be systematically investigated using appropriate study designs and methods including high quality randomized clinical trials to investigate their effectiveness, efficacy, therapeutic safety and costs in the future.

Background/objectives A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet. Methods This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350–400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments. Discussion/planned outcomes Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission. Trial registration ClinicalTrials.gov NCT03162289 . Registered on 22 May 2017

Background The decision making process for axillary dissection has changed in recent years for patients with early breast cancer and positive sentinel lymph nodes (LN). The question now arises, what is the optimal surgical treatment for patients with positive axillary LN (pN+). This article tries to answer the following questions: Is there a survival benefit for breast cancer patients with 3 or more positive LN (pN3+) and with more than 10 removed LN? Is there a survival benefit for high risk breast cancer patients (triple negative or Her2 + breast cancer) and with 3 or more positive LN (pN3+) with more than 10 removed LN? In pN + patients is the prognostic value of the lymph node ratio (LNR) of pN+/pN removed impaired if 10 or less LN are removed? Methods A retrospective database analysis of the multi center cohort database BRENDA (breast cancer under evidence based guidelines) with data from 9625 patients from 17 breast centers was carried out. Guideline adherence was defined by the 2008 German National consensus guidelines. Results 2992 out of 9625 patients had histological confirmed positive lymph nodes. The most important factors for survival were intrinsic sub types, tumor size and guideline adherent chemo- and hormonal treatment (and age at diagnosis for overall survival (OAS)). Uni-and multivariable analyses for recurrence free survival (RFS) and OAS showed no significant survival benefit when removing more than 10 lymph nodes even for high-risk patients. The mean and median of LNR were significantly higher in the pN+ patients with ≤10 excised LN compared to patients with > 10 excised LN. LNR was in both, uni-and multivariable, analysis a highly significant prognostic factor for RFS and OAS in both subgroups of pN + patients with less respective more than 10 excised LN. Multivariable COX regression analysis was adjusted by age, tumor size, intrinsic sub types and guideline adherent adjuvant systemic therapy. Conclusion The removal of more than 10 LN did not result in a significant survival benefit even in high risk pN + breast cancer patients.

Luminal A breast cancers respond well to anti-hormonal therapy (HT), are associated with a generally favorable prognosis and constitute the majority of breast cancer subtypes. HT is the mainstay of treatment of these patients, accompanied by an acceptable profile of side effects, whereas the added benefit of chemotherapy (CHT), including anthracycline and taxane-based programs, is less clear-cut and has undergone a process of critical revision. In the framework of the BRENDA collective, we analyzed the benefits of CHT compared to HT in 4570 luminal A patients (pts) with primary diagnosis between 2001 and 2008. The results were adjusted by nodal status, age, tumor size and grading. There has been a progressive reduction in the use of CHT in luminal A patients during the last decade. Neither univariate nor multivariate analyses showed any statistically significant differences in relapse free survival (RFS) with the addition of CHT to adjuvant HT, independent of the nodal status, age, tumor size or grading. Even for patients with more than 3 affected lymph nodes, there was no significant difference (univariate: p = 0.865; HR 0.94; 95% CI: 0.46-1.93; multivariate: p = 0.812; HR 0.92; 95% CI: 0.45-1.88). The addition of CHT to HT provides minimal or no clinical benefit at all to patients with luminal A breast cancer, independent of the RFS-risk. Consequently, risk estimation cannot be the initial step in the decisional process. These findings-that are in line with several publications-should encourage the critical evaluation of applying adjuvant CHT to patients with luminal A breast cancer.

Ayurveda, South Asia's largest and most relevant system of Traditional Medicine, holds a legal status akin to conventional Western medicine in India and elsewhere. There is an almost complete lack of data on the use of Ayurveda in Germany. The aim of this study was to investigate Ayurveda's utilization patterns, entry points, and factors influencing its use and the perception of Ayurveda among the German population. Basis of this manuscript was an online-representative survey which involved 4,065 participants aged 18-75 about the use and acceptance of Traditional, Complementary and Integrative Medicine (TCIM) in Germany. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022. The dataset was analyzed descriptively and inferentially. Altogether 9.3% (  = 377) of all survey participants (  = 4,065) had already used Ayurveda somehow, either more often (1.7%) or at least once in a lifetime (7.6%). Responders associated Ayurveda primarily with Indian Medicine (27.7%) and wellness (18%). Commonly used Ayurvedic services included non-medical treatments at wellness resorts/spas (48.3%), in outpatient practices (27.1%), and hotels (23.6%). 30.2% of the participants believe in Ayurveda's therapeutic potential. 76.7% of Ayurveda users find healthy nutrition important or very important. Nine predictors were found to classify Ayurveda users vs. non-users with spirituality and belief in Ayurveda's therapeutic efficacy as the most relevant ones. Ayurveda seems to be primarily used by well-educated and female individuals, often from higher-income groups and with a rather modern social milieu-orientation. Study results suggest that about every tenth German citizen has used Ayurveda in the past and about one third believes in its therapeutic potential. Because Ayurvedic therapies are often not evidence-based, there is an urgent need to perform high quality randomized controlled trials to investigate potential effects and safety of Ayurveda and how evidence-based Ayurveda treatments can be integrated into the German healthcare system.