CancerNCT04812704
Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery
A study testing Whey protein in people with Cancer and Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Surgery, Prehabilitation
- What is being tested?
- Whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Mar 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with operable cancer
- patient inform consent
- min 18 years old
- french or english speaking
Who cannot join
- neuromuscular pathology
- cardiorespiratory or orthopedic pathology that prevents physical activity
- cognitive or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Surgery, Prehabilitation
- Being tested
- Whey protein
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Patient receive protein supplement in liquid form after each exercice session
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (7)
Body composition (lean and fat mass)
Evaluated by an impedancemetry balance : pourcentage of lean and fat mass
Measured: 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)
Measured: 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
Measured: Once at the inclusion
Antropometric markers - height
Height (meters)
Measured: 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)
Measured: Once at the inclusion and once the day before surgery (3 weeks)
Antropometric markers - weight
Weight (kilograms)
Measured: 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
Measured: Once at the inclusion and once the day before surgery (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start9 Mar 2021
- Primary completion1 Apr 2021
- Study completion30 Apr 2022
Why it stopped: inclusion difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deswysen Yannick, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Yannick Deswysen, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812704
- Sponsor's protocol ID
- 2021/19JAN/022
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppléments protéinés en Association d'un Programme de préhabilitation Avant la Prise en Charge Chirurgicale d'un Cancer
- ClinicalTrials.gov ID
- NCT04812704
- Acronym / sponsor ID
- 2021/19JAN/022
- Conditions
- Cancer, Surgery, Prehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulty
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional complement | Experimental | Dietary Supplement: Whey proteinA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with operable cancer
- patient inform consent
- min 18 years old
- french or english speaking
Key exclusion criteria (3 listed)
- neuromuscular pathology
- cardiorespiratory or orthopedic pathology that prevents physical activity
- cognitive or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey proteinPatient receive protein supplement in liquid form after each exercice session | Dietary supplement | Nutritional complement |
Primary outcome
Adhesion rate of the use of nutritionnel complements after exercices before surgery for cancer
Time frame: 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.
7 secondary outcomes
Body composition (lean and fat mass)
Time frame: Once at the inclusion and once the day before surgery (3 weeks)
Muscle function
Time frame: Once at the inclusion and once the day before surgery (3 weeks)
Nutritional biological markers
Time frame: Once at the inclusion
Antropometric markers - height
Time frame: Once at the inclusion and once the day before surgery (3 weeks)
Muscle strength
Time frame: Once at the inclusion and once the day before surgery (3 weeks)
Antropometric markers - weight
Time frame: Once at the inclusion and once the day before surgery (3 weeks)
Antropometric markers - BMI
Time frame: Once at the inclusion and once the day before surgery (3 weeks)
Results and safety
The study was stopped early (reason given: inclusion difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick Deswysen, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein in people with Cancer and Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion rate of the use of nutritionnel complements after exercices before surgery for cancer (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.