Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition
NCT ID: NCT02516501
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
156 participants
INTERVENTIONAL
2015-06-30
2021-10-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Control group that will not receive advice to follow a ketogenic diet or reduce carbohydrates.
Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
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 (betaquik, vitaflo) plus (ii) 10g amino acids (MyAmino, dr. reinwald gmbh + co kg).
MyAmino
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.
betaquik
betaquik is a medium chain triglyceride (MCT) emulsion. One bottle is 225ml corresponding to 45g MCT fats.
Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
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 MyAmino analogous to Intervention group 1.
MyAmino
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.
Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Interventions
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MyAmino
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.
betaquik
betaquik is a medium chain triglyceride (MCT) emulsion. One bottle is 225ml corresponding to 45g MCT fats.
Radio(chemo)therapy
Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologicallý confirmed malignant Tumor
* Written informed consent
* Karnofsky index \>= 70
* 18 kg/m\^2 \< BMI \< 34 kg/m\^2
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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MVZ Leopoldina GmbH
OTHER
Responsible Party
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Principal Investigators
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Rainer J Klement, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Leopoldina Hospital Schweinfurt
Locations
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Department of Radiotherapy and Radiation Oncology
Schweinfurt, Bavaria, Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15025
Identifier Type: -
Identifier Source: org_study_id
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