Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

Neoplasms Clinical Trial

— KETOCOMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516501
• Other study ID #: 15025
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: October 2021

Study information

• Verified date: October 2022
• Source: MVZ Leopoldina GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Dietary Supplement:
• 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.

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

Locations

Country	Name	City	State
Germany	Department of Radiotherapy and Radiation Oncology	Schweinfurt	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
MVZ Leopoldina GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (9)

Klement RJ, Champ CE, Kämmerer U, Koebrunner PS, Krage K, Schäfer 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 R — View Citation

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: 10.10 — View Citation

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- — View Citation

Klement RJ, Schäfer 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. — View Citation

Klement RJ, Schäfer 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.2 — View Citation

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. — View Citation

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. — View Citation

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 May 2. doi: 10.1007/s00066-022-01941-2. [Epub ahead — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dropout rate	Dropout rates (intervention groups 1+2) to assess feasibility/tolerability of the intervention	5-6 weeks
Primary	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
Primary	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	Quality of life	Evaluation of quality of life using EORTC QLQ-C30 and site-specific questionnaires at start, in the middle and at the end of RT.	5-6 weeks
Secondary	Blood parameters	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.	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..
Secondary	Regression grade (TNM classification)	Only for colorectal carcinoma patients undergoing neoadjuvant RT: cTN status prior to and ypTN status after surgery	12 weeks
Secondary	Normal tissue toxicity after RT	Toxicity related to RT evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.	5-6 weeks