Conceptio › Archive › ClinicalTrials.gov
ClinicalTrials.gov public full text Public Domain

Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

MVZ Leopoldina GmbH · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
Open Source ↗
body-compositionnaneoplasmsradiation-therapy
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 betaquik® (vitaflo, Bad Homburg, Germany) and 10g MyAmino (dr. reinwald healthcare gmbh + co kg, Altdorf, Germany). * Group 2: Complete ketogenic diet plus 10g MyAmino/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 t
Conceptio Open Archive

Analyze & explore related research in Conceptio

Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.

This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗

Related documents

Record · ID 1263107
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive