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
- Inclusion and full written informed consent.
- Baseline BIA measurement and blood work
- RCT with weekly BIA assessments; at least one blood withdrawal ± concurrent dietary intervention
- Final BIA measurement and blood work after radiotherapy
Follow up For rectal carcinoma: Regression at time of surgery (c and p)