Raffaella Michela Rinaldi

Clinical Tolerability and Safety of Ketogenic Diet in Patients with Gynecological Malignancies Undergoing Radiotherapy: Preliminary Results of a Prospective, Randomized, Open-Label Trial (KOMPARC)

Background: Radiotherapy is a common treatment for gynecological malignancies, often accompanied by significant side effects that impact patient nutritional status. The ketogenic diet has been proposed as a complementary nutritional strategy to enhance treatment efficacy, manage side effects, and preserve body composition. However, its safety and feasibility in the oncological setting remain under-investigated. Methods: The KOMPARC study is a prospective, randomized controlled trial evaluating the adherence, safety, and clinical tolerability of a ketogenic diet versus a standard Mediterranean diet in patients with cervical and endometrial cancer undergoing radiotherapy. Before the start of the treatment, patients were randomized to either the ketogenic diet or the standard diet groups. Anthropometric measures, Hand Grip Test, and body composition parameters from bioimpedance analysis were taken before the start of treatment and at the end. Adherence, adverse events, and patient-reported outcomes were monitored throughout the treatment period. Results: A total of 33 patients were enrolled. Adherence rates were comparable between the KD and standard diet groups (46.1% vs. 25.0% interruption rate, p = 0.21). No significant differences were observed in the incidence of gastrointestinal toxicities (p = 0.56), diarrhea (p = 0.81), nausea (p = 0.94), or weight loss (p = 0.24). Both groups experienced significant weight reduction during therapy without differential loss of body cell mass or other body composition parameters. Quality of life assessments indicated varied symptom profiles, with the KD group reporting increased appetite loss and worry about weight. Conclusions: Preliminary findings suggest that the ketogenic diet is a safe and feasible nutritional intervention during radiotherapy for pelvic tumors. These results support further investigation into ketogenic dietary strategies as adjuncts in oncologic care.

Ladies project: large database in endometrial cancers for a personalized treatment

Abstract Purpose To compare Italian use with current international guidelines and to evaluate oncological outcomes and toxicity patterns of adjuvant radiation therapy (RT) for endometrial cancer (EC) in Italian women. Materials and methods To conduct a retrospective multicentre Italian study a large database was set up. Inclusion criteria were: accrual between 2010 and 2020, treatment with surgery, post-operative external beam RT (EBRT) and/or interventional radiotherapy (IRT) associated or not with adjuvant chemotherapy. Oncological outcomes, acute and late toxicities were analysed according to RT schedule and risk group. Results A total of 1848 patients, from 16 Italian RT centres were enrolled (median age 65 years, range 27–88). All patients received post-operative RT associated with chemotherapy in 31%. Patients were stratified on the basis of standard risk factors (Bosse et al. in Eur J Cancer 51:1742–50, 2015). After merging intermediate and high-intermediate risk classes into one intermediate group and including advanced and oligometastatic disease in the high-risk group, the low-risk group encompassed 124 patients, the intermediate-risk 1140, and the high risk 576. No low-risk patient developed local relapse (LR). Multivariate analysis showed that intermediate risk patients had a 2.5-fold increased risk of LR if treated with IRT alone vs EBRT-IRT boost. RT schedule did not impact significantly on LR in high risk patients. All acute toxicity parameters were highest in patients who received EBRT with simultaneous integrated boost (EBRT-SIB) and lowest in patients who received only IRT (p < 0.0001). Late toxicity was highest patients who received EBRT-SIB and lowest in those who were given EBRT with sequential boost (p < 0.0001). Conclusions This retrospective study showed that Italian administration of adjuvant RT for EC is in accordance with current international guidelines. IRT alone for low-risk patients and EBRT associated with vaginal IRT remain standard adjuvant approaches for EC.