Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition
Condition: Neoplasms
Study type: Interventional

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)
    


Intervention name(s): MyAmino; betaquik; Radio(chemo)therapy
Intervention type(s): Dietary Supplement; Dietary Supplement; Radiation
Intervention description(s): 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.; betaquik is a medium chain triglyceride (MCT) emulsion. One bottle is 225ml corresponding to 45g MCT fats.; Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Other intervention name(s): Master amino acid pattern (MAP)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketogenic Diet; Body composition; Radiation therapy