Last updated on February 2018

Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition


Brief description of study

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 betaquick (vitaflo, Bad Homburg, Germany) and 5-15 g Master Amino Acid Pattern (dr. reinwald healthcare gmbh+co kg, Schwarzenbruck, Germany).
  • Group 2: Complete ketogenic diet plus 5-15g Master Amino Acid Pattern/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)

Clinical Study Identifier: NCT02516501

Contact Investigators or Research Sites near you

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Rainer J Klement, PhD

Department of Radiotherapy and Radiation Oncology
Schweinfurt, Germany
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