AzTrials
AzTrials

NeoplasmsKETOCOMPNCT02516501

Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

A study testing MyAmino, betaquik and Radio(chemo)therapy in people with Neoplasms, run by MVZ Leopoldina GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplasms
What is being tested?
MyAmino, betaquik and Radio(chemo)therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteGermany
Study dates
Jun 2015to Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Palliative Treatment
  • Type I Diabetes
  • Pregnancy
  • Pacemaker and othe rmetallic parts that make BIA predictions unreliable
  • Unable to understand and speak German
  • Cognitive impairments
Show all 9Show fewer
  • Renal insufficiency
  • intake of carboanhydrase-inhibitors
  • Rare metabolic disorders that speak against a ketogenic diet

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Radiotherapy and Radiation Oncology

    Schweinfurt, Bavaria, 97421

Other trials in Germany

About this study

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

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

Read more

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)

Conditions
Neoplasms
Being tested
MyAmino, betaquik, Radio(chemo)therapy
Keywords
Ketogenic Diet, Body composition, Radiation therapy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyAminoDietary supplement

    Also called Master amino acid pattern (MAP)

    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.

  • betaquikDietary supplement

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

  • Radio(chemo)therapyRadiation

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

Study groups in NCT02516501
Study groupRoleWhat they receive
ControlActive comparatorControl group that will not receive advice to follow a ketogenic diet or reduce carbohydrates.
Receives: Radiation: Radio(chemo)therapy
Intervention group 1ExperimentalPatients 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).
Receives: Dietary Supplement: MyAmino; Dietary Supplement: betaquik; Radiation: Radio(chemo)therapy
Intervention group 2ExperimentalPatients 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.
Receives: Dietary Supplement: MyAmino; Radiation: Radio(chemo)therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dropout rate

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

    Measured: 5-6 weeks

  2. 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.

    Measured: 5-6 weeks

  3. 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.

    Measured: 5-6 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 5-6 weeks

  2. 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.

    Measured: 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..

  3. Regression grade (TNM classification)

    Only for colorectal carcinoma patients undergoing neoadjuvant RT: cTN status prior to and ypTN status after surgery

    Measured: 12 weeks

  4. 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.

    Measured: 5-6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2021
  4. Study completionOct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02516501
Sponsor's protocol ID
15025
Acronym
KETOCOMP
Status last verified
Oct 2022
First submitted
31 Jul 2015
Last updated
19 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26946138

  • 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.

    PubMed 30470845

  • 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.

    PubMed 28531663

  • 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.

    PubMed 32670812

  • 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.

    PubMed 32819413

  • 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.

    PubMed 33551218

  • 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.

    PubMed 34233255

  • 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.

    PubMed 34175978

  • 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.

    PubMed 35499696

Questions about this trial

What is this clinical trial studying?

A study testing MyAmino, betaquik and Radio(chemo)therapy in people with Neoplasms, run by MVZ Leopoldina GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dropout rate (time frame: 5-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02516501, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in