ClinicalTrials.gov
public full text
Public Domain
Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition
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
- Evaluation of Krio in Children and Adults With Epilepsy#901729
- A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body#858642
- Study of Radiolabeled ALXN2050 in Healthy Adult Males#868387
- Weight Loss With Microdose Tirzepatide: Real-World Outcomes in Patients Initiating Treatment Below 2.5 mg Weekly#1361648
- Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy#808072
Record · ID 1263107
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
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
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive