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

NCT04812704 | Terminated

• 1 other identifier: 2021/19JAN/022
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Surgery; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Body composition (lean and fat mass)

  Once at the inclusion and once the day before surgery (3 weeks)

• Muscle function

  Once at the inclusion and once the day before surgery (3 weeks)

• Nutritional biological markers

  Once at the inclusion

• Antropometric markers - height

  Once at the inclusion and once the day before surgery (3 weeks)

• Muscle strength

  Once at the inclusion and once the day before surgery (3 weeks)

Study Arms (1)

Nutritional complement

EXPERIMENTAL

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

Interventions

Whey protein DIETARY_SUPPLEMENT

Patient receive protein supplement in liquid form after each exercice session

Nutritional complement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yannick Deswysen, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 24, 2021
• Study Start: March 9, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 30, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)