Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Curative radiotherapy as indicated by the patient's disease and prescribed by the treating radiation oncologist

Curative radiotherapy

Two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule.

5:2 intermittent fasting

Rainer J Klement, Ph.D.

The intervention consists of the adoption of a 5:2 intermittent fasting diet during radiotherapy of breast cancer patients. The aim of the study was to assess the feasibility of this intervention and its impact on body composition and selected metabolic blood parameters.

The 5:2 intermittent fasting (FAST) intervention consisted of two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule. The minimum amount of time to count as a fasting day was 24 hours, but patients were advised to aim for a complete fasting day including the nights before and after that day. On a fasting day, only water and unsweetened tea or coffee was allowed. However, given that fat is the macronutrient interfering the least with the metabolic adaptions to fasting, while carbohydrates disturb the most \[26\], patients were allowed to consume small amounts of bone broth/meat broth, coconut oil, butter/ghee or heavy cream as an "emergency plan", i.e., in case that they felt they needed some energy-containing foods to complete an initiated fasting day.

The primary study outcome was the feasibility of the FAST intervention and its effects on longitudinal body composition changes from baseline until the final week of radiotherapy (body mass, fat mass, fat-free mass, muscle mass, extracellular and total body water). Secondary endpoints were absolute changes in metabolic parameters, hormones, and overall quality of life scores in the FAST group. As a surrogate marker for insulin resistance, the triglyceride-glucose index (TyG) was calculated according to TyG=ln⁡(fasting triglycerides \[mg/dl\]×fasting glucose \[mg/dl\]/ 2).

Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy

Data will be made available upon reasonable request

Used to measure feasibility. The intervention is rated as feasible if dropout rate is \<30%

Body mass (in kg) is measured by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Fat-free mass (in kg) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Skeletal muscle mass (in kg) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Total body water content (in L) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Extracellular water (in L) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

As a surrogate marker for insulin resistance, the triglyceride-glucose index (TyG) is calculated according to TyG=ln⁡(fasting triglycerides \[mg/dl\]×fasting glucose \[mg/dl\]/ 2)

MVZ Leopoldina GmbH

Symptoms and General Pathology

Body Weight

Body Weight Changes

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Dermatologic Agents

Vitamins

Herbal and Botanical

Vitamin D

Cholecalciferol

Sunscreening Agents

Vitamin D3

Calciferol

Coconut

Olive

The Paleolithic lifestyle (PL) intervention during radiotherapy consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed. Patients were supposed to start the PL intervention at least two days prior to the first irradiation and to protocol their food consumption on two days during the first week on the diet. They were also asked about their compliance to the PL intervention at each weekly measurement appointment.

This group is on a standard diet while receiving radiotherapy.

This intervention consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed.

Paleolithic lifestyle intervention

The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.

A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a "Paleolithic lifestyle" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching.

Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy

Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study

Will be made available upon reasonable request. Plan is also to publish all data of this and the KETOCOMP study (NCT02516501) together as soon as all analyses have been published.

Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)

Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level

Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels

Principle investigator

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Immunomodulating Agents

Immunologic Factors

Curative Radiotherapy

Immunotherapy

Hilary Elom, MD

Bo Lu, MD

Gregory Biedermann, MD

Ruobing Xue, MD

Salma Jabbour, MD

Yuhchyau Chen, MD, PhD

The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.

This aims to collect observational data that describe clinical (primary endpoint) and subclinical (secondary endpoint) cardiopulmonary toxicities from combined thoracic radiotherapy and immunotherapy up to 25 months after thoracic radiotherapy and 12 months after consolidation immunotherapy among patients with locally advanced lung cancer.

Plasma \& PBMC samples will be collected as per protocol required. Samples will be analyzed per protocol.

Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0

Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy	NCT05861362	Breast Cancer	Curative radiot... 5:2 intermitten...	18 Years - 75 Years	MVZ Leopoldina GmbH
Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy	NCT05861362	Breast Cancer	Curative radiot... 5:2 intermitten...	18 Years - 75 Years	MVZ Leopoldina GmbH
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy	NCT04574323	Breast Cancer Body Weight Cha...	Curative radiot... Paleolithic lif...	18 Years - 75 Years	MVZ Leopoldina GmbH
Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy	NCT06410300	Lung Cancer	Curative Radiot... Immunotherapy	18 Years -	University of Missouri-Columbia
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy	NCT04574323	Breast Cancer Body Weight Cha...	Curative radiot... Paleolithic lif...	18 Years - 75 Years	MVZ Leopoldina GmbH

Spots Global Cancer Trial Database for curative radiotherapy