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 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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Surgery; Prehabilitation
• Intervention / Treatment: Dietary supplement: Whey protein

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Nutritional complement; 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.

Dietary supplement: Whey protein; Patient receive protein supplement in liquid form after each exercice session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesion rate of the use of nutritionnel complements after exercices before surgery for 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.	3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Yannick Deswysen, MD, Cliniques Universitaires Saint-luc

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021/19JAN/022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No