Last updated on March 2016

Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

Brief description of study

Type of study: Pilot / phase I trial Study purpose To assess the impact of a dietary intervention during radio(chemo)therapy (RCT) on body composition changes Trial Treatment Patients will be split into a control group and intervention group 1. If willing to undertake a ketogenic diet for the duration of radiotherapy, patients are entered into intervention group 2. - Group 1: On irradiation days irradiation after overnight fast + ketogenic breakfast consisting of 50-250 ml betaquick® (vitaflo, Bad Homburg, Germany) and 5-15 g Master Amino Acid Pattern (dr. reinwald healthcare gmbh+co kg, Schwarzenbruck, Germany). - Group 2: Complete ketogenic diet plus 5-15g Master Amino Acid Pattern/day - Control: No dietary intervention. - All groups: Weight measurements and bioimpedance analysis (BIA) once per week, routine blood parameters and quality of life (QoL) questionnaire before, during and after RCT Endpoints Primary: - Feasibility of the dietary intervention during RCT, measured by dropout rates - Changes in body weight - BIA phase angle and quantities derived from BIA variables Secondary: - QoL - Toxicities - Blood parameters - Grade of regression at time of surgery in case of rectum carcinomas Inclusion criteria - One of the following tumor entities: - Breast carcinoma - Rectum carcinoma - Head & Neck Cancer - Histological confirmation of malignancy - Signed written informed consent - Karnofsky index ≥ 70 - Age between 18 and 75 years - BMI between 18 and 34 kg/m^2 Exclusion criteria - Palliative patients, in particular with metastasis - Type I diabetes - Pregnancy - Pacemaker and other metallic parts within the body - Known defects in enzymes necessary for ketogenesis, ketolysis, fatty acid oxidation or gluconeogenesis - Unable to speak or understand German - Cognitive impairments or psychological disorders - Renal insufficiency Planned accrual - 15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in intervention group 1 - 15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in control group - Minimum 5 patients of each tumor entity in intervantion group 2 Total: n ≥ 85 patients Study procedure 1. Inclusion and full written informed consent. 2. Baseline BIA measurement and blood work 3. RCT with weekly BIA assessments; at least one blood withdrawal ± concurrent dietary intervention 4. Final BIA measurement and blood work after radiotherapy Follow up For rectal carcinoma: Regression at time of surgery (c and p)

Clinical Study Identifier: NCT02516501

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Rainer J Klement, PhD

Department of Radiotherapy and Radiation Oncology
Schweinfurt, Germany
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