Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Body Weight

Breast Diseases

Skin Diseases

Lipidomic analysis for breast cancer patients

Stefano Magno, MD

Alessio Filippone, Ph.D.

Stefano magno, MD

Riccardo Masetti, MD

Cristina Rossi, Ph.D.

Maria M Rossi, M.Sc.

Claudia Maggiore, MD

Annalisa Di Micco, MD

Luana Forcina, M.Sc.

The goal of this clinical trial is to learn about breast cancer lipodome signature in patients waiting for surgery with different Body Mass Index.

The main question it aims to answer are:

* To highlight a specific lipidome molecular signature for breast cancer patients overweight and obese (BMI \> 25 Kg/m2) compared with patients of normal weight (BMI\<25 kg/m2).
* Evaluate the effect of the pool of biochemical, nutritional and anatomical-pathological data of breast cancer patients and the correlation between molecular profile and body weight.

Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.

Evaluate the correlation between some biomarkers derived from the lipidomic study (e.g. palmitic acid, stearic acid, oleic acid, palmitoleic acid and sapienic acid, arachidonic acid, dihomogammalinolenic acid, EPA, DHA, etc...) according to the BMI class considered.

Evaluate the correlation of molecular data with biochemical, nutritional and anatomical-pathological data of the patients and of the tumor (NLR -neutrophil-to-lymphocyte ratio), glycemia, cholesterol, blood pressure, triglycerides; TILs (percentage of lymphocytic infiltrate) and Ki67 (proliferation factor) on the surgical sample; W/H ratio, % FAT, % LEAN, phase angle at bioimpedance analysis in the study sample.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Head of UOS Breast Integrative Oncology

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Frailty

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Exercise Only

* 3 sessions per week
* Aerobic + Resistance Exercises

Exercise + Nutritional Guidance

* 3 sessions per week
* Aerobic + Resistance Exercises
* Dietary assessment at baseline and during with guidance on eating a healthy diet provided

Control group will receive no exercise or nutritional guidance

EXE+ Nutritional Guidance

David Bartlett, PhD

Ellie Miles

This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise.

This study aims to perform a randomised control trial of exercise or exercise plus nutritional guidance on the physiological and immunological health of adults diagnosed with chronic lymphocytic leukaemia (CLL). Recruited participants will be randomised to either 12 weeks of an exercise-only program, an exercise-plus nutritional guidance program or a no-exercise control group. Fasting blood samples collected at Baseline and 12 weeks will measure absolute CLL cell counts, immune function, and inflammatory and metabolic biomarkers. A series of physical fitness assessments will be assessed at baseline and 12 weeks to determine physiologic reserve and resilience against external stressors. Additionally, participants will be asked to return 12 weeks after completing the intervention to assess the legacy effects of the intervention on the same physiological and blood-based biomarkers of health.

Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks

Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia

Reassessment of CRF following 12 weeks of unguided exercise training

Reassessment of absolute number of CD19+/CD5+ CLL cells following 12 weeks of unguided exercise training

A blood sample will be taken and assessed for CD19+/CD5+ CLL frequency using flow cytometry and total lymphocyte counts to determine the absolute number of CLL cells in x10\^9/L

Cardiopulmonary exercise testing will be conducted to assess changes in fitness

Frailty will be determined by a series of validated physical function tests that provide a score of 0-1(Robust), 2 (Pre-Frail), 3-5 (Frail)

Estimated one repetition maximum and repetitions to failure using machine-based weights

Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage

Quality of life will be determined by the EORCT-QLQ-C30 questionnaire

Measurement of muscle oxygenation via near infrared spectroscopy during a single session of acute exercise

Measurement of in vitro B-CLL cell proliferation by flow cytometry

Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.	NCT06026631	Breast Cancer Lipid Cell; Tum... Nutrition Relat... Body Weight	Lipidomic analy...	18 Years - 65 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia	NCT06379282	Chronic Lymphoc... Frailty Muscle Function Immune Function Lipid Cell; Tum...	HIT EXE+ Nutritiona...	18 Years -	University of Surrey

Spots Global Cancer Trial Database for lipid cell; tumor