Clinical trial NCT02516501: Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition
Official title: Investigating the Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: Ketogenic Diet
Body composition
Radiation therapy
Lead sponsor: MVZ Leopoldina GmbH
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)


Eligibility 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

Primary outcomes:
measure: Dropout rate
timeFrame: 5-6 weeks
measure: Body composition
timeFrame: 5-6 weeks
measure: Phase angle
timeFrame: 5-6 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 5-6 weeks
measure: Blood parameters
timeFrame: 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..
measure: Regression grade (TNM classification)
timeFrame: 12 weeks
measure: Normal tissue toxicity after RT
timeFrame: 5-6 weeks
Other outcomes:
Locations:
city: Schweinfurt
country: Germany
facility: Department of Radiotherapy and Radiation Oncology
state: Bavaria
Study officials:
affiliation: Department of Radiation Oncology, Leopoldina Hospital Schweinfurt
name: Rainer J Klement, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.
citation: 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.
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 Jan 27.
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: 10.1016/j.clnu.2021.05.015. Epub 2021 May 31.
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-y. Epub 2021 Jun 27.
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 Nov;198(11):981-993. doi: 10.1007/s00066-022-01941-2. Epub 2022 May 2.