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

Neoplasms Clinical Trial

Official title: Investigating the Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition: A Pilot Trial

Status Completed

Clinical Trial 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)

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT02516501
• Study type: Interventional
• Source: MVZ Leopoldina GmbH
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Completion date: October 2021