Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD (IRENE-G study) - design and rational of a randomized controlled trial.

BACKGROUND: Graft-versus-host disease (GvHD) remains a major complication and limitation to successful allogeneic hematopoietic stem cell transplantation. Treatment of GvHD is challenging due to its heterogeneous nature of presentation, with steroids remaining the established first-line treatment. Long-term doses of systemic corticosteroids have many well-known side-effects including muscle atrophy. Despite the fact that reports in non-cancer clinical populations treated with glucocorticoids demonstrated that resistance training can reverse atrophy and weakness, no RCT has evaluated the potential of resistance training on preventing the disease- and treatment-induced loss of skeletal muscle mass and function in GvHD patients yet. In this context, ensuring adequate nutrition is important as protein deprivation may accelerate the wasting process. As GvHD patients are commonly found to be malnourished, nutritional medical care should be considered when investigating the effect of exercise in GvHD patients. Therefore, the aim of the present "Impact of Resistance Exercise and Nutritional Endorsement on physical performance in patients with GvHD" - Study (IRENE-G) is to evaluate the effects of resistance exercise in combination with nutritional endorsement on physical, nutritional and patient-reported outcomes in GvHD patients. METHODS: IRENE-G is a 24-week prospective interventional RCT. One hundred twelve participants will be randomly allocated (1:1) to one of two arms: resistance exercise and nutritional optimization (experimental) vs. nutritional optimization only (control). Participants in the experimental group will engage in a supervised, progressive moderate-to-high intensity resistance training that is consistent with exercise guidelines for cancer patients, while additionally receiving nutritional support/therapy. Subjects of the control group solely receive nutritional support/therapy based on individual needs. Participants will be assessed at baseline, at 8, 16, 24 weeks for physical performance and various physiological, nutritional and patient-reported outcomes. Follow-up will be 6 months after intervention completion. DISCUSSION: To our knowledge, this will be the first RCT to assess and compare the effects of a resistance intervention supplemented by nutritional support/therapy against nutritional support only on various health-related outcomes in GvHD patients. The study will contribute to our understanding of the value of exercise and nutritional endorsement in counteracting the negative consequences of GvHD and its treatment. TRIAL REGISTRATION: ClinicalTrials.gov : NCT05111834 . Registered 8 November 2021 - Retrospectively registered.

[Cervical cancer screening in Germany]. / Gebärmutterhalskrebsscreening in Deutschland.

Cytological examination for the early detection of cervical cancer (CCS) has been available in Germany since 1971. Women over the age of 20 are entitled to a Pap smear every year; however, thus far an organized screening program and personal invitations have been missing.The incidence rate of cervical carcinoma declined dramatically in the decades following the introduction of CCS, but the incidence rate has stagnated in recent years. The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). HPV tests have been approved by the American Food and Drug Administration (FDA) for CCS for several years. Furthermore, since 2006, the HPV vaccination has been offered as a form of primary prevention.As part of the German National Cancer Plan, the European Guideline for Cervical Cancer Screening was implemented and adopted into the 2013 Law on Cancer Screening and Registration. The Federal Joint Committee (G-BA) was commissioned with the implementation of an organized cervical cancer screening program.In April 2018, the G­BA published updated key points for the implementation of an organized nationwide screening program in Germany. While annual cytological screening for women between the ages of 20 and 34 will continue, women over the age of 34 years will be given a co-test comprising a Pap smear and an HPV test, every three years. Women between the ages of 20 and 60 will be contacted by their health insurance provider every five years and receive an information leaflet. After a test phase of at least six years, the new program will be evaluated.