Giuditta Chiloiro

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.

Low Tesla magnetic resonance guided radiotherapy for locally advanced cervical cancer: first clinical experience

Objective: Magnetic resonance–guided radiotherapy (MRgRT) represents an innovative approach for personalized radiotherapy treatments and its applications are being explored in various anatomical sites to fully understand its potential advantages. This study describes the first clinical experience of MRgRT application in patients with locally advanced cervical cancer (LACC) undergoing neoadjuvant chemoradiotherapy. The feasibility of the technique is evaluated and its toxicity profile and clinical outcomes are reported. Methods: Patients with LACC (International Federation of Gynecology and Obstetrics stage IIA–IVA) undergoing neoadjuvant chemoradiotherapy (CRT) on a 0.35T Tri-60-Co hybrid unit (ViewRay) were retrospectively compared with randomly selected patients treated with a standard linear accelerator. Total prescribed dose was 50.6 Gy (2.3 Gy/fraction) to planning target volume 1 (PTV1) and 39.6 Gy (1.8 Gy/fraction) to PTV2, delivered using a simultaneous integrated boost. Surgery was performed 8 weeks after the end of CRT. The effect of magnetic resonance guidance on replanning approaches, treatment-related toxicities, and pathologic response were assessed for each patient. Patient outcomes were noted and dosimetric comparisons performed between the 2 arms. Results: Nine patients with LACC treated from May 2018 to November 2018 were retrospectively enrolled and their records compared with the records of an equivalent cohort of randomly selected patients. Five replanning cases were performed in the MRgRT group and 0 in the linear accelerator group. Acute G1–G2 gastrointestinal toxicities were observed in 33.3% of MRgRT patients and in 55.5% of linear accelerator patients; acute G1–G2 genitourinary toxicities in 22.2% and 33.3%, respectively. No G3 toxicity was found except for neutropenia in 2 patients. No differences were observed in pathologic response between the 2 groups. Conclusions: Despite the retrospective nature of the observations and the low number of enrolled patients, the application of MRgRT in LACC appears to be safe and feasible with a favorable toxicity profile and response rates comparable to gold standard, supporting the setup of larger prospective studies to investigate the potentialities of this new technology.