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 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)

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* RT of one of the following tumor entities: Mammary carcinoma, colorectal carcinoma, head and neck carcinoma
* Histologicallý confirmed malignant Tumor
* Written informed consent
* Karnofsky index \>= 70
* 18 kg/m\^2 \< BMI \< 34 kg/m\^2

Exclusion Criteria:

* Palliative Treatment
* Type I Diabetes
* Pregnancy
* Pacemaker and othe rmetallic parts that make BIA predictions unreliable
* Unable to understand and speak German
* Cognitive impairments
* Renal insufficiency
* intake of carboanhydrase-inhibitors
* Rare metabolic disorders that speak against a ketogenic diet

• BACKGROUNDKlement RJ, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: I. Initial clinical experience with six prospectively studied patients. BMC Res Notes. 2016 Mar 5;9:143. doi: 10.1186/s13104-016-1959-9. PMID 26946138
• BACKGROUNDKlement RJ, Schafer G, Sweeney RA. A fatal case of Fournier's gangrene during neoadjuvant radiotherapy for rectal cancer. Strahlenther Onkol. 2019 May;195(5):441-446. doi: 10.1007/s00066-018-1401-4. Epub 2018 Nov 23. PMID 30470845
• BACKGROUNDKlement RJ, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: II. Protocol of a randomised phase I study (KETOCOMP). Clin Nutr ESPEN. 2016 Apr;12:e1-e6. doi: 10.1016/j.clnesp.2015.11.001. Epub 2016 Jan 15. PMID 28531663
• RESULTKlement RJ, Schafer G, Sweeney RA. A ketogenic diet exerts beneficial effects on body composition of cancer patients during radiotherapy: An interim analysis of the KETOCOMP study. J Tradit Complement Med. 2019 Mar 21;10(3):180-187. doi: 10.1016/j.jtcme.2019.03.007. eCollection 2020 May. PMID 32670812
• RESULTKlement RJ, Champ CE, Kammerer U, Koebrunner PS, Krage K, Schafer G, Weigel M, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: III-final results of the KETOCOMP study for breast cancer patients. Breast Cancer Res. 2020 Aug 20;22(1):94. doi: 10.1186/s13058-020-01331-5. PMID 32819413
• RESULTKlement RJ, Weigel MM, Sweeney RA. A ketogenic diet consumed during radiotherapy improves several aspects of quality of life and metabolic health in women with breast cancer. Clin Nutr. 2021 Jun;40(6):4267-4274. doi: 10.1016/j.clnu.2021.01.023. Epub 2021 Jan 27. PMID 33551218
• RESULTKlement RJ, Koebrunner PS, Meyer D, Kanzler S, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: IV. Final results of the KETOCOMP study for rectal cancer patients. Clin Nutr. 2021 Jul;40(7):4674-4684. doi: 10.1016/j.clnu.2021.05.015. Epub 2021 May 31.