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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT04812704
Collaborator
(none)
50
1
1
12.7
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Whey protein
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Suppléments protéinés en Association d'un Programme de préhabilitation Avant la Prise en Charge Chirurgicale d'un Cancer
Actual Study Start Date :
Mar 9, 2021
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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)

  3. Nutritional biological markers [Once at the inclusion]

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

  4. Antropometric markers - height [Once at the inclusion and once the day before surgery (3 weeks)]

    Height (meters)

  5. 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)

  6. Antropometric markers - weight [Once at the inclusion and once the day before surgery (3 weeks)]

    Weight (kilograms)

  7. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques universitaires Saint-Luc Brussels Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Yannick Deswysen, MD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deswysen Yannick, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT04812704
Other Study ID Numbers:
  • 2021/19JAN/022
First Posted:
Mar 24, 2021
Last Update Posted:
Mar 24, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 24, 2021