Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition (KETOCOMP)

October 17, 2022 updated by: MVZ Leopoldina GmbH

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Schweinfurt, Bavaria, Germany, 97421
        • Department of Radiotherapy and Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Control group that will not receive advice to follow a ketogenic diet or reduce carbohydrates.
Radiation: Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Experimental: Intervention group 1
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).
Radiation: Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Dietary supplement: MyAmino
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)
Dietary supplement: betaquik
betaquik is a medium chain triglyceride (MCT) emulsion. One bottle is 225ml corresponding to 45g MCT fats.
Experimental: Intervention group 2
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.
Radiation: Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Dietary supplement: MyAmino
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rate
Time Frame: 5-6 weeks
Dropout rates (intervention groups 1+2) to assess feasibility/tolerability of the intervention
5-6 weeks
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.
5-6 weeks
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.
5-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5-6 weeks
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.
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..
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
12 weeks
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.
5-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MVZ Leopoldina GmbH

Investigators

  • Principal Investigator: Rainer J Klement, PhD, Department of Radiation Oncology, Leopoldina Hospital Schweinfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15025 (Other Identifier: City of Hope Comprehensive Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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