Colorectal CancerPROTEOSNCT05677958
Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement
A study testing 125 mL Fortimel/Nutridrink Compact Protein in people with Colorectal Cancer and Lung Cancer, run by Nutricia Research at 14 sites in 7 countries.
Trial summary
The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Lung Cancer
- What is being tested?
- 125 mL Fortimel/Nutridrink Compact Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 17 Jan 2019to 17 Dec 2021
- 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
- Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV
- Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks
- Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- Age ≥ 18 years
- Written informed consent
Who cannot join
- Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization
- Received radiotherapy within 2 months prior to the study
- Weight loss >10% in the last 6 months
- Body Mass Index < 20.0 kg/m2
- Life expectancy < 3 months
- Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice
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- Presence of ileostoma or ileal pouch
- Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator
- Known pregnancy or lactation
- Current alcohol or drug abuse in the opinion of the investigator
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Netherlands5 sites
Amphia Ziekenhuis
Breda
Maastricht University Medical Center
Maastricht
St. Antonius Hospital
Nieuwegein
Máxima Medisch Centrum
Veldhoven
Zaans Medisch Centrum
Zaandam
Estonia2 sites
North Estonia Medical Centre
Tallinn
Tartu University Hospital
Tartu
Poland2 sites
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan
Hospital of Szczecin
Szczecin
About this study
Official title: Protein Intake in Patients With Colorectal or Lung Cancer During First Line Treatment With Chemo (Radio) - or Immunotherapy When Receiving a Low Volume, Energy Dense and High Protein Oral Nutritional Supplement: a Randomized, Controlled Study
The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.
- Conditions
- Colorectal Cancer, Lung Cancer
- Being tested
- 125 mL Fortimel/Nutridrink Compact Protein
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
125 mL Fortimel/Nutridrink Compact ProteinDietary supplement
125 mL Fortimel/Nutridrink Compact Protein®* two servings per day (300 kcal, 18 g protein per serving).
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | 125 mL Fortimel/Nutridrink Compact Protein Receives: Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
Measured: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Secondary outcomes (2)
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
Measured: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Change of body weight.
change of body weight measured with weighting scale
Measured: during 12 weeks (baseline till end of intervention at week 12]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start17 Jan 2019
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test group: receiving daily 2 servings of a low volume, energy dense and high protein oral nutritional supplement (ONS) Control group: not receiving any study product. These subjects will be receiving standard of care.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677958
- Sponsor's protocol ID
- MPR16TA06151
- Acronym
- PROTEOS
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2022
- Last updated
- 10 Jan 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Intake in Patients With Colorectal or Lung Cancer During First Line Treatment With Chemo (Radio) - or Immunotherapy When Receiving a Low Volume, Energy Dense and High Protein Oral Nutritional Supplement: a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05677958
- Acronym / sponsor ID
- PROTEOS / MPR16TA06151
- Conditions
- Colorectal Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 10 Jan 2023 (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 PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test group: receiving daily 2 servings of a low volume, energy dense and high protein oral nutritional supplement (ONS) Control group: not receiving any study product. These subjects will be receiving standard of care.
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein125 mL Fortimel/Nutridrink Compact Protein |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV
- Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks
- Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- Age ≥ 18 years
- Written informed consent
Key exclusion criteria (12 listed)
- Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization
- Received radiotherapy within 2 months prior to the study
- Weight loss >10% in the last 6 months
- Body Mass Index < 20.0 kg/m2
- Life expectancy < 3 months
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 |
|---|---|---|
| 125 mL Fortimel/Nutridrink Compact Protein125 mL Fortimel/Nutridrink Compact Protein®* two servings per day (300 kcal, 18 g protein per serving). | Dietary supplement | Test group |
Primary outcome
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
Time frame: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
2 secondary outcomes
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
Time frame: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Change of body weight.
Time frame: during 12 weeks (baseline till end of intervention at week 12]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 125 mL Fortimel/Nutridrink Compact Protein in people with Colorectal Cancer and Lung Cancer, run by Nutricia Research at 14 sites in 7 countries.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands, Belgium, Estonia, Poland, Lithuania and 2 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary. (time frame: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-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 10 Jan 2023.