Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition
- Conditions
- Neoplasms
- Interventions
- Radiation: Radio(chemo)therapyDietary Supplement: MyAminoDietary Supplement: betaquik
- Registration Number
- NCT02516501
- Lead Sponsor
- MVZ Leopoldina GmbH
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Radio(chemo)therapy Control group that will not receive advice to follow a ketogenic diet or reduce carbohydrates. Intervention group 2 Radio(chemo)therapy 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. Intervention group 1 Radio(chemo)therapy 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). Intervention group 1 betaquik 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). Intervention group 1 MyAmino 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). Intervention group 2 MyAmino 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.
- Primary Outcome Measures
Name Time Method Dropout rate 5-6 weeks Dropout rates (intervention groups 1+2) to assess feasibility/tolerability of the intervention
Body composition 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.
Phase angle 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.
- Secondary Outcome Measures
Name Time Method Quality of life 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.
Blood parameters 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.
Regression grade (TNM classification) 12 weeks Only for colorectal carcinoma patients undergoing neoadjuvant RT: cTN status prior to and ypTN status after surgery
Normal tissue toxicity after RT 5-6 weeks Toxicity related to RT evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
Trial Locations
- Locations (1)
Department of Radiotherapy and Radiation Oncology
🇩🇪Schweinfurt, Bavaria, Germany