Emanuele Rinninella

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.

Skeletal muscle mass as a prognostic indicator of outcomes in ovarian cancer: a systematic review and meta-analysis

Muscle mass plays a key role in predicting clinical outcomes in cancer. This systematic review and meta-analysis aimed to evaluate whether computed tomography (CT) scan indexes of muscle mass quantity and quality could be used as prognostic factors in ovarian cancer. Three electronic bibliographic databases (MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials) were used to conduct a systematic literature search from inception to January 2020. The primary outcome was overall survival. Pooled analyses of hazard ratios (HRs) and 95% confidence intervals (CIs) were performed with Review Manager 5.3. Heterogeneity was assessed by measuring inconsistency (I A total of 15 studies were included in the systematic review, of which six studies (1226 patients) were included in the meta-analysis. Summary unadjusted HRs (HR 1.11, 95% CI 0.84 to 1.46, p=0.47) and adjusted HRs (HR 1.10, 95% CI 0.84 to 1.43, p=0.49) did not show a significant association between low skeletal muscle index and overall survival (p>0.05) in ovarian cancer. Instead, although the quality of evidence was low, pooled data of three studies, comprising 679 patients, showed a significant association between low skeletal muscle radiodensity and poor overall survival (HR 1.63, 95% CI 1.28 to 2.07, p<0.0001). Moreover, the heterogeneity between studies precluded the possibility of performing a meta-analysis and reaching conclusions for progression free survival, disease free survival, surgical complications, and chemotoxicity. This work suggested that the measurement of skeletal muscle radiodensity by routine CT scan at diagnosis, with standardization of diagnostic criteria, could be a reliable tool to select at risk patients and to individualize effective nutritional strategies. However, prospective homogeneous studies with a larger number of patients are required to confirm these results.