Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

NCT02516501 | Completed

• 1 other identifier: 15025
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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
• 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

Conditions

Neoplasms

Keywords

Ketogenic Diet; Body composition; Radiation therapy

Outcome Measures

Primary Outcomes (3)

• Dropout rate

  Dropout rates (intervention groups 1+2) to assess feasibility/tolerability of the intervention

  5-6 weeks

• Body composition

  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.

  5-6 weeks

• Phase angle

  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.

  5-6 weeks

Secondary Outcomes (4)

• Quality of life

  5-6 weeks

• 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..

• Regression grade (TNM classification)

  12 weeks

• Normal tissue toxicity after RT

  5-6 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Radiation: Radio(chemo)therapy

Intervention group 1

EXPERIMENTAL

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).

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

Intervention group 2

EXPERIMENTAL

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.

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

Interventions

MyAmino DIETARY_SUPPLEMENT

MyAmino is a supplement containing the eight essential amino acids. MyAmino has a theoretical net nitrogen utilization of 99%, so that almost no glucose will be created out of the maino acids.

Also known as: Master amino acid pattern (MAP)

Intervention group 1; Intervention group 2

betaquik DIETARY_SUPPLEMENT

betaquik is a medium chain triglyceride (MCT) emulsion. One bottle is 225ml corresponding to 45g MCT fats.

Intervention group 1

Radio(chemo)therapy RADIATION

Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.

Control; Intervention group 1; Intervention group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• kg/m\^2 \< BMI \< 34 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• MVZ Leopoldina GmbH: lead

Study Sites (1)

Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, 97421, Germany

Location

Related Publications (9)

• Klement RJ, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: I. Initial clinical experience with six prospectively studied patients. BMC Res Notes. 2016 Mar 5;9:143. doi: 10.1186/s13104-016-1959-9.

  PMID: 26946138 BACKGROUND

• Klement RJ, Schafer G, Sweeney RA. A fatal case of Fournier's gangrene during neoadjuvant radiotherapy for rectal cancer. Strahlenther Onkol. 2019 May;195(5):441-446. doi: 10.1007/s00066-018-1401-4. Epub 2018 Nov 23.

  PMID: 30470845 BACKGROUND

• Klement RJ, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: II. Protocol of a randomised phase I study (KETOCOMP). Clin Nutr ESPEN. 2016 Apr;12:e1-e6. doi: 10.1016/j.clnesp.2015.11.001. Epub 2016 Jan 15.

  PMID: 28531663 BACKGROUND

• Klement RJ, Schafer G, Sweeney RA. A ketogenic diet exerts beneficial effects on body composition of cancer patients during radiotherapy: An interim analysis of the KETOCOMP study. J Tradit Complement Med. 2019 Mar 21;10(3):180-187. doi: 10.1016/j.jtcme.2019.03.007. eCollection 2020 May.

  PMID: 32670812 RESULT

• Klement RJ, Champ CE, Kammerer U, Koebrunner PS, Krage K, Schafer G, Weigel M, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: III-final results of the KETOCOMP study for breast cancer patients. Breast Cancer Res. 2020 Aug 20;22(1):94. doi: 10.1186/s13058-020-01331-5.

  PMID: 32819413 RESULT

• Klement RJ, Weigel MM, Sweeney RA. A ketogenic diet consumed during radiotherapy improves several aspects of quality of life and metabolic health in women with breast cancer. Clin Nutr. 2021 Jun;40(6):4267-4274. doi: 10.1016/j.clnu.2021.01.023. Epub 2021 Jan 27.

  PMID: 33551218 RESULT

• Klement RJ, Koebrunner PS, Meyer D, Kanzler S, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: IV. Final results of the KETOCOMP study for rectal cancer patients. Clin Nutr. 2021 Jul;40(7):4674-4684. doi: 10.1016/j.clnu.2021.05.015. Epub 2021 May 31.

  PMID: 34233255 RESULT

• Klement RJ, Meyer D, Kanzler S, Sweeney RA. Ketogenic diets consumed during radio-chemotherapy have beneficial effects on quality of life and metabolic health in patients with rectal cancer. Eur J Nutr. 2022 Feb;61(1):69-84. doi: 10.1007/s00394-021-02615-y. Epub 2021 Jun 27.

  PMID: 34175978 RESULT

• Klement RJ, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: V. Final results of the KETOCOMP study for head and neck cancer patients. Strahlenther Onkol. 2022 Nov;198(11):981-993. doi: 10.1007/s00066-022-01941-2. Epub 2022 May 2.

  PMID: 35499696 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rainer J Klement, PhD

  Department of Radiation Oncology, Leopoldina Hospital Schweinfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 6, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

DE (1)