We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified March 2017 by MVZ Leopoldina GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT02516501
First Posted: August 6, 2015
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
dr. reinwald healthcare gmbh+co. kg
Vitaflo International, Ltd
Information provided by (Responsible Party):
MVZ Leopoldina GmbH
  Purpose

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 betaquick® (vitaflo, Bad Homburg, Germany) and 5-15 g Master Amino Acid Pattern (dr. reinwald healthcare gmbh+co kg, Schwarzenbruck, Germany).
  • Group 2: Complete ketogenic diet plus 5-15g Master Amino Acid Pattern/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)


Condition Intervention Phase
Neoplasms Dietary Supplement: Ketogenic breakfast Dietary Supplement: Ketogenic diet Radiation: Radio(chemo)therapy Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition: A Pilot Trial

Further study details as provided by MVZ Leopoldina GmbH:

Primary Outcome Measures:
  • Dropout rate [ Time Frame: 5-6 weeks ]
    Dropout rates (intervention groups 1+2) to assess feasibility/tolerability of the intervention

  • Body composition [ Time Frame: 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 [ Time Frame: 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:
  • Quality of life [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 12 weeks ]
    Only for colorectal carcinoma patients undergoing neoadjuvant RT: cTN status prior to and ypTN status after surgery

  • Normal tissue toxicity after RT [ Time Frame: 5-6 weeks ]
    Toxicity related to RT evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.


Estimated Enrollment: 85
Study Start Date: June 2015
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Control group that will not receive advice to follow a ketogenic diet or reduce carbohydrates.
Radiation: Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Experimental: Intervention group 1
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 (betaquick, vitaflo) plus (ii) 5g, 10g or 15g amino acids (MAP, dr. reinwald gmbh+co kg) depending on whether the phase angle derived from the first BIA measurement is greater than, within or less than the normal range for that age and gender, respectively.
Dietary Supplement: Ketogenic breakfast
The breakfast consisting of increasing doses up to 250 ml of betaquick plus MAP will be taken directly after each RT fraction.
Other Names:
  • betaquick MCT drink
  • Master amino acid pattern (MAP)
Radiation: Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Experimental: Intervention group 2
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 MAP analogous to Intervention group 1.
Dietary Supplement: Ketogenic diet
MAP will be used as a supplement for the ketogenic diet. MAP has a net nitrogen utilization of 99%, so that almost no glucose will be created out of the maino acids.
Other Name: Master amino acid pattern (MAP)
Radiation: Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516501


Contacts
Contact: Reinhart A Sweeney, MD +49 9721 7206420 rsweeney@leopoldina.de
Contact: Rainer J Klement, PhD +49 9721 7206424 rklement@leopoldina.de

Locations
Germany
Department of Radiotherapy and Radiation Oncology Recruiting
Schweinfurt, Bavaria, Germany, 97421
Contact: Reinhart A Sweeney, MD    +49 9721 7206420    rsweeney@leopoldina.de   
Principal Investigator: Rainer J Klement, PhD         
Sponsors and Collaborators
MVZ Leopoldina GmbH
dr. reinwald healthcare gmbh+co. kg
Vitaflo International, Ltd