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

Not Applicable

Terminated

• Conditions: Cancer; Prehabilitation; Surgery

• Registration Number: NCT04812704
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-03-05
• Study Start: 2021-03-09
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Primary Completion: 2021-04-01
• Study Completion: 2022-04-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• patient with operable cancer
• patient inform consent
• min 18 years old
• french or english speaking

Exclusion Criteria

• neuromuscular pathology
• cardiorespiratory or orthopedic pathology that prevents physical activity
• cognitive or psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adhesion rate of the use of nutritionnel complements after exercices before surgery for cancer	3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Body composition (lean and fat mass)	Once at the inclusion and once the day before surgery (3 weeks)	Evaluated by an impedancemetry balance : pourcentage of lean and fat mass
Antropometric markers - BMI	Once at the inclusion and once the day before surgery (3 weeks)	BMI (kg/m²) :weight and height will be combined to report BMI in kg/m²
Nutritional biological markers	Once at the inclusion	These variables will be studied by: prealbumin (g/L) and albumin (g/L) measures
Muscle function	Once at the inclusion and once the day before surgery (3 weeks)	This variable will be studied by the 6-minutes walk test (meters)
Antropometric markers - height	Once at the inclusion and once the day before surgery (3 weeks)	Height (meters)
Muscle strength	Once at the inclusion and once the day before surgery (3 weeks)	This variable will be studied by the hand grip test (kilograms)
Antropometric markers - weight	Once at the inclusion and once the day before surgery (3 weeks)	Weight (kilograms)

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium