Skip to main content
OpenTrials
Completed

NCT Number: NCT02516501

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, 97421, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyAmino

Dietary Supplement

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.

Other names: Master amino acid pattern (MAP)

betaquik

Dietary Supplement

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

Radio(chemo)therapy

Radiation

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

Primary outcomes

  1. Dropout rate

    Time frame: 5-6 weeks

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

  2. Body composition

    Time frame: 5-6 weeks

    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.

  3. Phase angle

    Time frame: 5-6 weeks

    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.

Secondary outcomes

  1. Quality of life

    Time frame: 5-6 weeks

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

  2. Blood parameters

    Time frame: Blood parameters will be determined up to one week before the first RT fraction, at least once during their RT course (after an expected 3 weeks) and during their last week 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.

  3. Regression grade (TNM classification)

    Time frame: 12 weeks

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

  4. Normal tissue toxicity after RT

    Time frame: 5-6 weeks

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

Sponsors and collaborators

Lead sponsor

MVZ Leopoldina GmbH

Other

Registry information

Official study title

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

Acronym: KETOCOMP

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2015
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.