Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

Summary

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)

Conditions

• Neoplasms

Interventions

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.

DIETARY_SUPPLEMENT

betaquik

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

RADIATION

Radio(chemo)therapy

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

Sponsors & Collaborators

• MVZ Leopoldina GmbH

  lead OTHER

Principal Investigators

• Rainer J Klement, PhD · Department of Radiation Oncology, Leopoldina Hospital Schweinfurt

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2021-10-31

Completion

2021-10-31

Countries

• Germany

Study Locations