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

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).

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 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.

MyAmino

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

betaquik

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

Radio(chemo)therapy

Rainer J Klement, PhD

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)

Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

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

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

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.

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.

Evaluation of quality of life using EORTC QLQ-C30 and site-specific questionnaires at start, in the middle and at the end of RT.

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.

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

Toxicity related to RT evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.

MVZ Leopoldina GmbH

Neoplasms

All Conditions

Symptoms and General Pathology

Infections

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Squamous Cell

Papilloma

Pain

Virus Diseases

Deglutition Disorders

Squamous Cell Carcinoma of Head and Neck

Oropharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Stomatognathic Diseases

Quality of Life

Eligible patients with histologically verified early stage squamous cell carcinoma of the oropharynx.

Patients will be treated in accordance with current hospital protocols with transoral robotic surgery (T1-2, N1, M0) or radio(chemo)therapy (any T-stage, any N-stage, M0).

In the absence of severe mobidity patients with early stage disease (T1-2, N1, M0) were offered TORS, as an alternative to the standard of care (radiotherapy).

Primary Trans Oral Robotic Surgery (TORS)

As the standard of care radiotherapy was offered to all of the patients. Patients that qualified for both TORS and radiotherapy were free to choose between the two.

Christian von Buchwald, MD, dr. med.

To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.

Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery \& Audiology at Copenhagen University Hospital, Rigshospitalet.

All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included.

Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.

Saliva samples for later analysis of composition and changes in composition following treatment.

Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma

Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.

Assessed using modified barium swallowing studies (MBSS). Evaluated as change from baseline.

Assessed using fiber endoscopic evaluation of swallowing function (FEES). Evaluated as change from baseline.

Assessed using the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Evaluated as change from baseline.

Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Evaluated as change from baseline.

Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H\&N35 questionnaire. Evaluated as change from baseline.

Assessed using a pain diary based on a 10 point visual analog scale (VAS). 0 being no pain and 10 the most severe pain. Registrered in increments of 1 (i.e. 3,5 is not an accepted score whereas 3 or 4 are).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition	NCT02516501	Neoplasms	MyAmino betaquik Radio(chemo)the...	18 Years - 75 Years	MVZ Leopoldina GmbH
Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition	NCT02516501	Neoplasms	MyAmino betaquik Radio(chemo)the...	18 Years - 75 Years	MVZ Leopoldina GmbH
Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma	NCT03418909	Oropharynx Canc... Pain Swallowing Diso... Quality of Life Saliva Altered Human Papilloma...	Primary Trans O... Radio(chemo)the...	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for radio(chemo)therapy