Clinical trial NCT05677958: Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lung Cancer
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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.
timeFrame: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Secondary outcomes:
measure: Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
timeFrame: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
measure: Change of body weight.
timeFrame: during 12 weeks (baseline till end of intervention at week 12]
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
city: Szczecin
country: Poland
facility: Hospital of Szczecin
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte EPE
Study officials:
References: