Effects of a combined exercise and dietary intervention on body composition, physical functioning and fatigue in patients with ovarian cancer: results of the PADOVA trial.

BACKGROUND: Guidelines recommend to include exercise and dietary advice in standard care for patients with cancer, based on evidence primarily derived from patients with breast cancer. Its applicability to patients with ovarian cancer is uncertain due to differences in patient characteristics and treatments. The PADOVA trial examined the effectiveness of a combined exercise and dietary intervention on fat-free mass (FFM), physical functioning, and fatigue. METHODS: In total, 81 patients with ovarian cancer were randomised to the exercise and dietary intervention (n = 40) or control (n = 41) group. Measurements were performed before chemotherapy, after chemotherapy, and 12 weeks later. FFM was assessed by bioelectrical impedance analysis, and physical functioning and fatigue were assessed using questionnaires. Intervention effects were assessed on an intention-to-treat basis using linear mixed models. RESULTS: FFM and physical functioning increased, and fatigue decreased significantly over time in both groups. No significant difference between the groups were found for FFM (ß = -0.5 kg; 95% CI = -3.2; 2.1), physical functioning (ß = 1.4; 95% CI = -5.4; 8.3) and fatigue (ß = 0.7; 95% CI = -1.5; 2.8). CONCLUSIONS: During treatment, both groups improved in FFM, physical functioning, and fatigue. The intervention group, however, did not demonstrate additional benefits compared to the control group. This highlights the need for caution when extrapolating findings from different cancer populations to patients with ovarian cancer.

Rationale and study protocol of the Physical Activity and Dietary intervention in women with OVArian cancer (PADOVA) study: a randomised controlled trial to evaluate effectiveness of a tailored exercise and dietary intervention on body composition, physical function and fatigue in women with ovarian cancer undergoing chemotherapy.

INTRODUCTION: As a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising quality of life. Exercise and dietary interventions can positively influence body composition, physical fitness and function, and fatigue in patients with cancer. However, there are no data from randomised controlled trials on the effectiveness of exercise and dietary interventions in patients with ovarian cancer. Due to a complex disease trajectory, a relatively poor survival and distinct disease-induced and treatment-induced side effects, it is unclear whether exercise and dietary interventions that were shown to be feasible and effective in other types of cancer produce comparable results in patients with ovarian cancer. The aim of this article is to present the design of the multicentre randomised controlled Physical Activity and Dietary intervention in OVArian cancer trial and to describe how the exercise and dietary intervention is tailored to specific comorbidities and disease-induced and treatment-induced adverse effects in patients with ovarian cancer. METHODS AND ANALYSIS: Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line (neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy. Primary outcomes are body composition, physical function and fatigue. Outcome measures will be assessed before the start of chemotherapy, 3 weeks after completion of chemotherapy and 12 weeks later. The exercise and dietary intervention was tailored to ovarian cancer-specific comorbidities and adverse effects of ovarian cancer and its treatment following the i3-S strategy. ETHICS AND DISSEMINATION: This study has been approved by the medical ethical committee of the Amsterdam UMC (reference: 018). Results of the study will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry (NTR6300).

Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): study protocol of a randomised controlled, multicentre, superiority trial.

INTRODUCTION: Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI. METHODS AND ANALYSIS: EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmoll-1) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis. ETHICS AND DISSEMINATION: Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results. TRIAL REGISTRATION NUMBER: Registered in the Dutch Trial Register: NL5572.