Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition (KETOCOMP)

MVZ Leopoldina GmbH

Status: Completed

Conditions: Neoplasms

Treatments: Dietary Supplement: MyAmino; Dietary Supplement: betaquik; Radiation: Radio(chemo)therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02516501

15025 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 156 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 3 patient groups

Control

Active Comparator group

Description:

Control group that will not receive advice to follow a ketogenic diet or reduce carbohydrates.

Treatment:

Radiation: Radio(chemo)therapy

Intervention group 1

Experimental group

Description:

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).

Treatment:

Dietary Supplement: betaquik

Dietary Supplement: MyAmino

Radiation: Radio(chemo)therapy

Intervention group 2

Experimental group

Description:

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.

Treatment:

Dietary Supplement: MyAmino

Radiation: Radio(chemo)therapy