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

## TL;DR

This study explores whether a ketogenic diet is safe and well-tolerated in gynecological cancer patients undergoing radiotherapy, finding it feasible and comparable to a standard diet.

## Contribution

The study provides preliminary evidence on the safety and tolerability of a ketogenic diet in oncology patients receiving radiotherapy.

## Key findings

- Adherence to the ketogenic diet was comparable to the standard diet, with no significant differences in gastrointestinal side effects.
- Both diet groups experienced weight loss without significant differences in body composition changes.
- Quality of life assessments showed varied symptom profiles, with the ketogenic group reporting more appetite loss and weight-related concerns.

## Abstract

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.