Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2021-12-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

randomised controlled, open label, parallel-group, multi-centre and multicountry study

Study Groups

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Test group

125 mL Fortimel/Nutridrink Compact Protein

Group Type ACTIVE_COMPARATOR

125 mL Fortimel/Nutridrink Compact Protein

Intervention Type DIETARY_SUPPLEMENT

125 mL Fortimel/Nutridrink Compact Protein®\* two servings per day (300 kcal, 18 g protein per serving).

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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125 mL Fortimel/Nutridrink Compact Protein

125 mL Fortimel/Nutridrink Compact Protein®\* two servings per day (300 kcal, 18 g protein per serving).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No