Chronic rhinosinusitis (CRS) affects 1-4% of the adult population. The etiology of this multifactorial, chronic disease, which leads to a significant impairment of the quality of life, often accompanied by nasal polyposis, is not fully understood. In the past decade, it was presumed that the disease, which causes characteristic eosinophilic infiltration of the nasal mucosa, is triggered by an enhanced (but not classical allergic IgE-type) immune response against fungal organisms in the nasal mucus. If this supposition is correct, then it appears obvious that the administration of amphotericin B nasal spray in adequate concentration following endoscopic polypectomy should be advantageous for these patients, and might even reduce the number of recurrent cases. To check on this assumption, we conducted a prospective randomized placebo-controlled trial involving 33 patients, 30 of whom remained in the study throughout. Patients with nasal polyposis were operated on with an endoscopic technique between 1 November 2005 and 1 October 2006; group A (14 randomly selected patients) were treated with a nasal spray containing 5 mg/ml amphotericin B, while the placebo group B (16 randomly selected patients) received a nasal spray lacking amphotericin B. We evaluated our results with the aid of a modified Lund-Mackay CT score, the SNAQ-11 test (which assesses changes in the symptoms), a quality of life test and endoscopy. The SPSS 14.0 for Windows program was utilized to process the data of examinations performed preoperatively and 1 year postoperatively. The CT scores of the group A patients 1 year after the operation exhibited wide scattering, without signs of recovery. The CT scores of the group B patients indicated a slight improvement, though this did not prove significant relative to group A. Both the SNAQ-11 test and the quality of life test revealed a significant improvement in each group, but the degrees of change in these tests did not differ significantly between the two groups of patients. The endoscopic findings indicated a slight improvement to the advantage of the amphotericin B-treated group 12 months after the operation. These results lead to the conclusion that the administration of amphotericin B nasal spray to patients operated on for nasal polyposis does not give rise to a significant alteration in either CT score, clinical symptoms, or quality of life. The more favorable clinical aspects observed in the amphotericin B-treated group during the endoscopic follow-up did not correspond to an improvement in the symptoms. In connection with the conclusions drawn from this study, the authors discuss the controversial data available on the fungal etiology of CRS. They critically analyze the contradictory observations and conclusions of seven recent clinical studies.

Recombinant IL-2 protein has shown many immunostimulatory effects in a variety of human tumors. However, the clinical use of rIL-2 is limited by common and serious side effects after systemic administration. IL-2 expression plasmids may circumvent these drawbacks, producing high local IL-2 concentrations that cause limited or no systemic side effects. Due to the superficial growth of squamous cell carcinoma of the head and neck (HNSCC) are readily accessible for direct intratumoral injection and therefore an optimal target for such a gene therapy approach. There has been evidence for local and systemic activation of immune cells by peritumoral injections of IL-2 in patients with advanced HNSCC (Whiteside et al. 1993; Cortesina et al. 1994; De Stefani et al. 1996). We now perform a placebo-controlled, dose-rising study of the safety and tolerability of a single intratumoral injection of hIL-2 plasmid at four dose levels formulated in DOTMA/Chol in patients with primary untreated head and neck squamous cell cancer (HNSCC) TNM stage II-IV. The patients will be monitored for the occurrence of any adverse reactions to the given medication. In addition, we will determine whether the intratumoral administration of the plasmid induces and or enhances tumor-specific host responses at the immunological and or clinical level.

Background A cancer diagnosis can cause severe emotional distress and affect quality of life as well as social relationships. The transition from inpatient to outpatient treatment is burdened by stressful uncertainties and a gap of psycho-oncological care. In addition, further barriers, such as information deficits or fear of stigmatization, might hinder cancer patients to use psycho-oncological face-to-face interventions. Online interventions can be a low-threshold adjunct to existing face-to-face services. This study aims to evaluate the effect of the online self-help program epos (emotion-based psycho-oncological online self-help) on improving symptoms of anxiety and depression in German-speaking cancer patients. Methods A randomized controlled trial (RCT) is carried out in a parallel group design. N = 325 patients will be enrolled in the trial, randomly assigned to an intervention and a control group. While the intervention group has access to nine modules of epos , the control group gets access to an informational website. Participants will complete online questionnaires at baseline (T0), after the intervention (T1) and three-month follow-up (T2). Primary outcome is a combined measure of depression and anxiety. Secondary outcomes include psychological distress, anxiety, depression, quality of life, emotional control, posttraumatic growth, and satisfaction with epos . Participants are at least 18 years old, have a cancer diagnosis, currently receive cancer treatment or aftercare, have sufficient German language competence, and have access to the Internet. Exclusion criteria are severe mental comorbidities (i.e. severe depression, suicidality) or somatic comorbidities (i.e. visual disabilities). Discussion The results of this study will provide information about acceptability, feasibility, and efficacy of epos in improving symptoms of depression and anxiety in cancer patients and thus contribute to the research on web-based interventions. If found efficacious, epos will improve psycho-oncological care in cancer patients in transition from inpatient to outpatient care and in those who struggle to find adequate psycho-oncological support due to other (perceived) barriers.

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Zusammenfassung Ziel der Studie Der Einbezug potenzieller Endnutzerinnen und -nutzer in den Entwicklungsprozess digitaler Interventionen ermöglicht, dass entwickelte Programme den Bedürfnissen, Anforderungen und Erwartungen der zukünftigen Nutzerinnen und Nutzer entsprechen, was sich wiederum positiv auf die Akzeptanz und Adhärenz auswirkt. In diesem Beitrag wird ein partizipativer Entwicklungsansatz für die patientennahe Gestaltung der psychoonkologischen Online-Selbsthilfe epos vorgestellt, welche Unterstützung im Umgang mit seelischen und körperlichen Beschwerden bieten soll. Methodik Patientinnen und Patienten wurden an 2 Stellen in den Entwicklungsprozess einbezogen. Zu einem frühen Zeitpunkt der Entwicklung wurden halbstandardisierte Tiefeninterviews mit Betroffenen unterschiedlicher Krebsarten (N=10) durchgeführt und qualitativ hinsichtlich ihrer Sicht auf (1) die Krebserkrankung und (2) die Ausgestaltung einer Online-Selbsthilfe auf inhaltlicher, struktureller und gestalterischer Ebene ausgewertet. Zu einem späteren Zeitpunkt wurde ein Prototyp der Online-Selbsthilfe in einer Pilotphase evaluiert. Ergebnisse Die inhaltsanalytische Auswertung der Interviews mit insgesamt N=742 Codierungen ergab fünf inhaltliche Hauptkategorien (Veränderungen im Alltags- und Zukunftserleben, Veränderungen der sozialen Beziehungen, Verarbeitungsmechanismen, Kontrollverlust, schwierige Emotionen), die Aufschluss über die zentralen Herausforderungen und Belastungen der Betroffenen geben. Besonders starke Emotionen zeigten die Interviewten bei Themen, die den zwischenmenschlichen Bereich betrafen, sodass in der Online-Selbsthilfe zusätzlich zum emotionsbasierten Fokus auch ein Schwerpunkt auf soziale Beziehungen gelegt wurde. Strukturelle und gestalterische Implikationen für die Entwicklung bezogen sich vor allem auf Übersichtlichkeit und Nutzerfreundlichkeit. Die Pilotphase ermöglichte die Überprüfung, ob die vorab durch die Betroffenen beschriebenen Anforderungen an eine Online-Selbsthilfe erfüllt wurden. Schlussfolgerung Der Einbezug von Patientinnen und Patienten in den Entwicklungsprozess der digitalen Online-Selbsthilfe epos konnte Hinweise für die Ausgestaltung auf verschiedenen Ebenen geben. Mögliche Endnutzerinnen und -nutzer in mehreren Entwicklungsphasen einzubeziehen kann sicherstellen, dass die Anforderungen und Anregungen nicht nur aus Sicht der Entwicklerinnen und Entwickler, sondern auch aus Sicht der späteren Nutzerinnen und Nutzer ausreichend berücksichtigt wurden. Diese Erkenntnisse bestätigen die Bedeutsamkeit einer patientenorientierten Herangehensweise bei der Entwicklung digitaler Angebote.