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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04812704
• Other study ID #: 2021/19JAN/022
• Status: Terminated
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 30, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Prehabilitation
• Surgery

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Nutritional biological markers	These variables will be studied by: prealbumin (g/L) and albumin (g/L) measures	Once at the inclusion
Secondary	Antropometric markers - height	Height (meters)	Once at the inclusion and once the day before surgery (3 weeks)
Secondary	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)
Secondary	Antropometric markers - weight	Weight (kilograms)	Once at the inclusion and once the day before surgery (3 weeks)
Secondary	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)