Control group that will not receive advice to follow a ketogenic diet or reduce carbohydrates.

Patients who will receive each radiotherapy (RT) fraction after an overnight fast and subsequently ingest a ketogenic breakfast consisting of (i) up to 250 ml of a medium chain triglyceride drink (betaquik, vitaflo) plus (ii) 10g amino acids (MyAmino, dr. reinwald gmbh + co kg).

Patients who will follow a ketogenic diet throughout the whole period of RT, Patients don't have to fast prior to each RT fraction, but will receive MyAmino analogous to Intervention group 1.

MyAmino is a supplement containing the eight essential amino acids. MyAmino has a theoretical net nitrogen utilization of 99%, so that almost no glucose will be created out of the maino acids.

MyAmino

betaquik is a medium chain triglyceride (MCT) emulsion. One bottle is 225ml corresponding to 45g MCT fats.

betaquik

Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.

Radio(chemo)therapy

Rainer J Klement, PhD

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)

Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

Investigating the Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition: A Pilot Trial

Dropout rates (intervention groups 1+2) to assess feasibility/tolerability of the intervention

This is a composite measure of several parameters obtained from the bioimpedance scale (mBCA 515, seca Germany). Body weight and composition derived from bioimpedance analysis will be assessed at least once per week. Body composition is composed of fat mass, fat free mass, total body water, extracellular water and intracellular water.

The phase angle is a raw parameter of bioimpedance analysis and will be tracked weekly at a total of 19 frequencies (1, 1.5,2,3,5,7.5,10,15,20,30,50,75,100,150,200,300,500,1000 kHz). The Focus will be on the Phase angle at 50kHz which is a standard frequency of most BIA devices.

Evaluation of quality of life using EORTC QLQ-C30 and site-specific questionnaires at start, in the middle and at the end of RT.

This is a composite measure of relevant blood parameters including small blood count, glucose, albumin, urea, HbA1c, beta-hydroxybutyrate, triglycerides, HDl and LDL cholesterol, creatinine, liver enzymes, insulin, IGF-1, TSH, free T3 and T4.

Only for colorectal carcinoma patients undergoing neoadjuvant RT: cTN status prior to and ypTN status after surgery

Toxicity related to RT evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition	NCT02516501	Neoplasms	MyAmino betaquik Radio(chemo)the...	18 Years - 75 Years	MVZ Leopoldina GmbH
Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition	NCT02516501	Neoplasms	MyAmino betaquik Radio(chemo)the...	18 Years - 75 Years	MVZ Leopoldina GmbH

Spots Global Cancer Trial Database for myamino

Every month we try and update this database with for myamino cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for myamino

Every month we try and update this database with for myamino cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for myamino cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.