Nutritional and Metabolic Diseases

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Whey Protein

Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)

Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician + 20 g (2 x 10 g) of whey proteins

Whey protein

Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician

Nutritional counseling

Emanuele Cereda, MD, PhD

Riccardo Caccialanza, MD

Nutritional derangements are very common in cancer patients and negatively affect survival, morbidity and quality of life. Intervention trials have demonstrated that nutritional counseling can improve energy balance, nutritional status and quality of life in patients undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events such as an impairment of nutritional status and quality of life. The nutritional properties of whey protein have recently raised attention. In view of the high content in cysteine these proteins can positively stimulate the synthesis of glutathione which, in turn, could contribute to the modulation of whole-body and cellular redox state. However, evidence on the role of this dietary intervention in cancer patients is limited.

Whey Protein Supplementation in Cancer Patients

Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)

Change in body weight during the study (at 1 month and 3 months)

Change in quality of life during the study (at 1 month and 3 months) as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 \[EORTC QLQ-C30\]

Change in handgrip strength during the study (at 1 month and 3 months)

Norgine

Akern Srl

IRCCS Policlinico S. Matteo

Physician

Complement System Proteins

A prospective study will be carried out including adult patients with neoplasia who should benefit in their therapeutic strategy from oncological surgery. About fifty patients will be recruited in the oncology / surgery department at the Saint-Luc University Clinics in Brussels. Patients will be assessed at the initial consultation and after the pre-habilitation period, ie the day before the operation.

Dietary monitoring will be carried out in parallel with a physical and respiratory preparation program (prehabilitation) and the intake of protein nutritional supplements in the form of powder to be diluted will be carried out after each exercise session.

Patient receive protein supplement in liquid form after each exercice session

Yannick Deswysen, MD

The aim of study is to analyse the feasibility of the use of nutritionnal complements after exercices before surgery for cancer.

Body composition, muscle function and muscle mass will be analyse too.

Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery

Suppléments protéinés en Association d'un Programme de préhabilitation Avant la Prise en Charge Chirurgicale d'un Cancer

The feasibility of this outcome will be assess by the adhesion rate : (number of protein shots taken) / (number of protein shots prescribed). The adhesion will be validated if\> 75% of the holds are respected.

Evaluated by an impedancemetry balance : pourcentage of lean and fat mass

This variable will be studied by the 6-minutes walk test (meters)

These variables will be studied by: prealbumin (g/L) and albumin (g/L) measures

This variable will be studied by the hand grip test (kilograms)

BMI (kg/m²) :weight and height will be combined to report BMI in kg/m²

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Principal Investigator

Nervous System Diseases

Symptoms and General Pathology

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Sarcopenia

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Herbal and Botanical

Soy Bean

This group received dietary guidance and soy protein intervention for 3 months

This group received dietary guidance and whey protein intervention for 3 months

This group received dietary guidance and ｍltodextrin for 3 months

The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.

soy protein

The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.

whey protein

The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.

placebo

Kang Yu, MD

Yu Zang, MD

Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Previous studies have shown that increased protein intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength, function, and overall survival. However, most previous studies have focused on the intervention of whey protein, while the protective effect of soybean protein on lung cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an agreement.

So, this study aims to explore the effects of soy and whey protein on muscle, gut microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to provide a reference for further nutrition treatment.

This study will last 6 months. For the duration of the study, an anticipated total of 90 participants will be randomly assigned to receive either a 30-gram protein supplement or a placebo daily. There will be a total of 5 study visits, and dietary records, questionnaires, blood and stool collection, and functional testing will occur at all study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.

Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia

Effects of Soy Protein and Whey Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia（LCRS）: a Randomized, Double-blind, Controlled Clinical Study

Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.

Measured by FRAIL scale (0-5) with higher scores meaning better physical function.

Measured by EuroQol- 5 Dimension scale (0-5) with higher scores meaning better Quality of life.

The stool samples of participants before and after intervention were collected and analized by 16S rRNA.

Completing initially planned chemotherapy course is defined as good tolerance; dose adjustment, delayed completion or interruption of treatment are considered as poor tolerance.

Measured after initiation of chemotherapy using the WHO Toxicity Grades (gradeI-IV) with higher grades neaning severer chemotheraphy toxicity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Whey Protein Supplementation in Cancer Patients	NCT02065726	Solid Tumors	Whey protein Nutritional cou...	18 Years -	IRCCS Policlinico S. Matteo
Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery	NCT04812704	Cancer Surgery Prehabilitation	Whey protein	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia	NCT05771207	Lung Cancer Sarcopenia	soy protein whey protein placebo	18 Years -	Peking Union Medical College Hospital
Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery	NCT04812704	Cancer Surgery Prehabilitation	Whey protein	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Whey Protein Supplementation in Cancer Patients	NCT02065726	Solid Tumors	Whey protein Nutritional cou...	18 Years -	IRCCS Policlinico S. Matteo
Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery	NCT04812704	Cancer Surgery Prehabilitation	Whey protein	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Spots Global Cancer Trial Database for whey protein

Every month we try and update this database with for whey protein cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.